LUPRON VICTIMS HUB
| Home  |   Risks  | Deaths | AERS |  Documents |  History   |  NLVN  |  Lawsuits  |  Relevant Info  |  Links  |  Media  |  Contact   
........"HOME / INDEX"........

See Lupron Side Effects Survey Results: Part One by Chandler Marrs, PhD. 09-01-16.

07-16-16: Did you receive your Lupron/leuprolide injection by a gowned, gloved, and goggled healthcare worker? ... See Universal Disregard of NIOSH Precautions During the Handling, Preparation, and Administration of the "hazadous drug" Lupron/leuprolide'.

Scorecard Chemical Profile: Leuprolide = "Reproductive & Developmental Toxicant". Goserelin also is recognized as a "Reproductive & Developmental Toxicant".

CDC/NIOSH "List of Antineoplastic Hazardous Drugs" ... Leuprolide = "Hazardous Drug".

Leuprolide (Lupron) on all NIOSH 'Antineoplastic Hazardous Drug Lists': 1999, 2004, 2010, 2012, 2014. Also on NIOSH 'Antineoplastic Hazardous Drug Lists' are goserelin (Zoladex), triptorelin (Trelstar), and since 2012 degarelix (Firmagon).

Nafarelin (Synarel) and Ganirelix, previously on (above) 2010 & 2012 NIOSH 'Antineoplastic Hazardous Drug Lists', were removed in 2014, and instead placed under NIOSH 2014 'List of Non-antineoplastic Drugs that meet NIOSH criteria for Reproductive Hazard List'. (Cetrorelix [Cetrotide] is also on this latter 2014 list.)

Merck Manual "Warnings & Precautions"... "Leuprolide /Lupron = Hazardous agent"; Synarel = Hazardous agent,

Material Safety Data Sheet: MSDS: Abbott's leuprolide = Hazardous per OSHA criteria

Leuprolide = Hazardous Substances Databank Number 6518 (search Table of Contents for "Hazardous Substances Databank No.")

CA. Prop65: "Reproductive toxicants" = leuprolide, goserelin

Other Names for Lupron, as well as Names for 'other-than-Lupron' GnRHas

Different Country's Names for leuprolide

Incomplete A-Z list of lupron / leuprolide's 'Off-Label Uses'

National Women's Health Network's Nov/Dec 2008 Cover Story: "Lupron - What Does It Do To Women's Health?"

9-24-09: Lupron = "very large increased risk of developing various major heart problems" (men with prostate CA studied)

07-09-08: "New findings may be final nail in [Lupron's] coffin" (re: prostate findings)

Renowned Endo MD: ... "Lupron Doesn't Work At All"

If Amy Doseretz' study had been submitted to FDA, lupron would never have been granted approval for prostate cancer (20% increase in mortality - see "FDA Approval would be denied")

Another renowned Endo MD is 'no fan of Lupron'

ERC (Endometriosis Research Center) 2003 Survey: "48.19% indicated Lupron was INTOLERABLE and NOT HELPFUL AT SYMPTOM RELIEF"

ERC 2003 Survey: "23.33% Suffered Lasting Effects For UP TO 5 OR MORE YEARS After Lupron"

Lupron "rarely helps" Prostate Cancer

Decrease seen in use of Lupron, leuprolide, androgen deprivation as a result of decrease in Medicare reimbursement

"Who Is This Woman", poem by Kas (She is You and Me)

"MY POEM" by Rachelle Fenner

U.S. Dept. of Justice: 'TAP = Criminal Enterprise'

Lupron Sales Rep Items - 5 'Lupron Depot Pens' - for sale on eBay - end date 3/1/09

Lupron & Autism: "Significant Misrepresentations - The Evolution of the Lupron Protocol"

Lupron i-petition, with 1000+ signatures (re: endo)

Lupron side effects on PatientsVille.com

Medications.com Lupron stories (47 pages)

Federal Register Notice 5-1-96: Findings of Scientific Misconduct re: fraudulent Lupron research and fabricated data in published studies (gyn)

ORI's Findings of Scientific Misconduct involving lupron

Published Lupron Article "Retracted" for Fraudulent Data (re: gyn)

1998 Letter to Editor re: Lupron Fraud, Conflict$ of Interest

Another Published Article re: leuprolide "Retracted" for 'Undiscoverable Reasons' (re: autism)

"Clinical & Financial Issues" Halt Alzheimers/leuprolide trial (Note: latter link removed - this link mentions only "funding constraints")

10-03-01 - TAP pays $875 million to settle criminal charges & civil liabilities re: lupron

Lupron for prostate CA = "more harm than good"

"Suspicious" Promotion of Lupron on TV

Harvard's ESCR Team Will Not Use Lupron For Its Egg Donors

LupronSUQS -- Serious UNANSWERED QuestionS

Millican's US Attorney Draft Document

Millican's 2003 Congressional Testimony on the Risks of Lupron & ART

Example of Attorney Letters Rec'd re: Lupron

Example of Using Leuprolide on Women BEFORE use of Leuprolide in Animals (note "Conclusion")

National Lupron Victim Network's Court Witness Statement

Info on Lupron, by Merck Manual

June 2011: Revised Lupron 3.75 mg label

European Medicines Evaluation Agency asked to conduct safety study of Enantone/lupron

DailyMed: Lupron Depot Description

DailyMed - Lupron

|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

Send a MedWatch Report to FDA about lupron/leuprolide adverse event(s)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

**********************************************************************************

For "NOTEWORTHY NEWS / ACTION ALERT" please scroll down page (approximately 1/4). "INTRODUCTION" to this website is found near bottom of page.

**********************************************************************************

"LUPRON" is "the blockbuster", most prescribed, brand name of JUST ONE "GnRHa". (Generic names for Lupron are leuprolide and leuprorelin; other brand names include Prostap, Enantone, Procrin, Lucrin - for a comprehensive list of other Lupron brand names globally, scroll down in left column for "Other Names for Lupron" & "Different Country's Names").

GnRHa's are a class of drugs known as "Gonadotrophin-Releasing Hormone analog/agonists" (prescribed to men, women, and children for a variety of indications - see 'Incomplete A-Z List of 'Off-Label Uses''). There are MANY OTHER GnRHa's besides Lupron - such as Triptorelin (aka Trelstar, Decapeptyl, Gonapeptyl), Goserelin (aka Zoladex), Histrelin (aka Vantas, Supprelin), Nafarelin (aka Synarel), Buserelin (aka Suprefact, Suprecor). Note links at immediate left identifying the classification of Lupron/leuprolide as a "Hazardous Drug" (as well as goserelin, Zoladex, triptorelin, Trelstar, Degarelix, and Firmagon being listed as a "Hazardous Drug").

Whether you have been prescribed Lupron or any other GnRHa, you should be aware that “Gonadotrophin-releasing hormone (GnRH) analogs are not like any other medication currently available for treatment of disease.  As we continue to learn more about these analogs’ mechanisms of action, it is increasingly apparent that they do not just affect the gonadal [sex] hormones, but are powerful modulators of autonomic neural function.” (emphasis mine) (citing Mathias et al; June 1995. Letter. ‘Placebo Controlled Study Randomizing Leuprolide Acetate’. Digestive Diseases and Sciences, 40(6):1406-07). Because a PubMed search of this citation does not identify or include Mathias' comment and produces only author "Drossman's" comment (page 1405), the above statement by Mathias et al. on page 1406 has been provided here fyi (and for those interested: page 1407). ... And in elaboration: the latter studies involve claims of "remarkable results" using lupron off-label to "treat" severe gastrointestinal (GI) disorders - but it should be noted that lupron/GnRHa's are known to cause adverse GI effects (links to adverse events databases are provided below). See "Chronic intestinal pseudo-obstruction due to buserelin-induced formation of anti-GnRH antibodies". And consider the posted comment from one lupron GI clinical trial participant whose results have apparently not made it into any subsequent published medical literature. Also note in "Introduction to this website'' at bottom of this page that, with no prior history of GI disease, I subsequently DEVELOPED severe gastrointestinal problems *after* lupron.

“[C]onceivably, LHRH [GnRH] analogues may be antigenic:  if so, antibodies may neutralize the effect of LHRH [GnRH] and its analogues, or may even cause immune-related disorders. ... [T]he long-term safety of LHRH [GnRH] analogues have not yet been fully investigated, especially when we are dealing with structures drifting farther and farther from the original model.” (emphasis mine) (Gueriguian, JL; Schaffenburg, CA; Chiu, Y;  Berliner, V.  Trends in Drug Development with Special Reference to the Testing of LHRH [GnRH] Analogues.  In LHRH [GnRH] and its Analogues, Elsevier Science Publishers B.V. 1984, p. 507-516).

Despite more than 30 years and millions of patients, the long-term safety of GnRHa's has undergone little investigation. And to quote a 1994 comment by Dr. Redwine: "Inclusion of patients with a poor response to GnRHa therapy has not always occurred in outcome analysis in the published literature."

The following is a brief review of noteworthy investigations and results:

In 1999 - 17 years ago - the FDA conducted an investigation into the adverse events reported for lupron: the FDA concluded that "the nature of reported adverse events for males and females is quite similar - indicating that the events are much more likely to be due to the drug than age, gender, or underlying disorder." (emphasis mine). The FDA decided to take "no action" - see "1999 FDA Review of Lupron" . Small, isolated studies over the years have been done - i.e. in 2002 a prospective study found "joint disorder/pain = 76%, depression = 35%, hypertension = 7.04%, weight changes = 14.8%" with lupron treated patients. And, to name just a few, safety label changes have added hepato-biliary disorders, interstitial lung disease, and convulsions to lupron's label.

The first comprehensive look at GnRHa-induced depression and suicide took place in 2010 in the EU, with the recommendation that all GnRH analogs' product information identify that "the risk of depression and mood changes should be mentioned and warnings should be included, in a consistent manner and for all indications, in the product information of all medical products in the EU containing a GnRH agonist." Please note: the results of this 2010 report are nearly completely redacted, because "disclosure would be prejudicial to commercial interests" (emphasis mine): See the Takeda study on 'depression/suicide and GnRHa use' and note the censure of 'Study Results', 'Discussion' and 'Conclusions' on pages 4 - 7, and ponder the TOTAL BLACK-OUT of 'Key Findings' and 'Conclusions' for pages 87 - 175. For further details on the censure of the results of this study, see post below, at the 'Noteworthy News' entry, which is dated "rec'd December 2012".

In 2010, the FDA conducted a safety review of male use of GnRHa's for prostate cancer treatment, and advised changes to the "Warnings & Precaution" sections of the GnRHa label for male use, adding "the risk of diabetes, heart attack, sudden cardiac death, and stroke". This FDA safety review identified there are "no known comparable studies that have evaluated the risks of diabetes and heart disease in women and children taking GnRHa's." (emphasis mine). Also in 2010, a database search identified that men on long-term androgen deprivation therapy ("ADT" - consisting of GnRHa's) had an increased risk of colorectal cancer; and a similar database review of men's prostate cancer ADT treatment concluded an elevation in risk of cataracts.

I have been writing to the FDA since 1992 (see 'Letters' for additional communications and FDA responses); in 2001 I submitted a detailed draft outline to the Assistant US Attorney (subsequently provided to the FDA's Office of Criminal Investigation) concerning the serious problems related to lupron's clinical trials, including cardiovascular events (see specifically: "Section II A"). See also 2009 letter to FDA Commisioner.

It should be noted that the first reported case of angina and myocardial infarction (heart attack) in a woman using lupron was published in 1994, and the potential risk of GnRH agonists causing an increased risk of coronary artery disease in women was raised in 1989 (in this article about the use of GnRHa's to treat premenstrual syndrome it is stated "Clinicians and patients must be aware that this [GnRHa] therapy is an extreme therapeutic measure; medical castration may increase the patient's risk of osteoporosis and coronary artery disease.") (emphasis mine). And there have been several other reports of women having a heart attack during leuprolide's off-label use in ovulation induction. As of 1995, the following adverse events had been reported to the FDA from women using lupron: death, arrhythmias, myocarditis, cardiovascular accident, coronary artery disease, cerebrovascular accident, ECG abnormalities, ventricular fibrillation, heart arrest, right-sided heart failure, myocardial infarction, chest pain, substernal chest pain, palpitations, tachycardia, superventricular tachycardia, peripheral vascular disorder.

In the meantime, THOUSANDS of women have requested and are requesting an investigation into the wide-ranging and long-term physical side effects (often debilitating) of lupron ... so where is the investigation? For additional information and other links to US petitions requesting an investigation and ban of lupron, as well as a lupron petition from France (all detailing sad horror stories post-lupron), see 'Links page'. And take note that Dr. Gueriguian (a former FDA Medical Officer involved with the initial 1985 FDA approval of lupron for pallliative treatment of prostate cancer) has stated more recently in his capacity as an expert medical witness in a female lupron product liability lawsuit that "Lupron causes irreversible side effects and permanent severely disabling health problems."

In a 2012 New York Times article, it was stated that "[a] recent inquiry into maternal deaths in the UK found that OHSS [ovarian hyperstimulation syndrome] following high-dose IVF [in vitro fertilization - consisting of lupron/GnRHa's] is now one of the leading causes of maternal mortality in England and Wales ... Considering the number of women who've taken these drugs [lupron] over the past 25 years, you'd think much more rigorous studies and analysis would have been done on them." ... ... (One of the 'rationals' given to women for utilizing lupron/GnRHa's during an IVF cycle is 'to prevent the risk of OHSS', yet case reports identify that lupron/GnRHa's have CAUSED OHSS: See "OHSS associated with the use of the GnRHa leuprolide acetate" [and note mesh headings ["MH"] in this Medline abstract: "leuprolide/*adverse effects/ovarian hyperstimulation syndrome [OHSS]/*chemically induced/drug therapy"]. See also "Ovarian hyperstimulation syndrome [OHSS] following the sole administration of agonistic analogues of GnRH [leuprolide/triptorelin], in which it is noted that "OHSS can occur following the sole administration of GnRHa irrespective of the preparation used and the administration protocal." See also here and here.)

The National Women's Health Network (NWHN) "believes that the [FDA] agency should review the safety and efficacy of Lupron® for both its approved and off-label uses. ... a registry should be established to monitor the drug’s effect on women, as well as on any children exposed to Lupron® ... In order to halt this drug from causing damage to even one more woman's health, a concerted effort of women, physicians, health officials, researchers and media is needed. The decision to raise public awareness so that other women could be spared the physical, emotional and financial burdens Lupron causes would truly be in the interest of women’s health around the country. The people who are considering taking Lupron are the ones who have the right to know that they are risking a lifetime of symptoms that may cost them their jobs, spouses, savings and quality of life." (emphasis mine) This NWHN conviction that the FDA should review the safety of lupron was published in the NWHN's cover story on lupron issued 7 years ago. Why no FDA investigation into the effects on women? Why no retrospective (or prospective) studies investigating the incidence and range of long-term lupron/GnRHa adverse events in women? Why no Congressional investigations into lupron (see 'Links' page)? Why no "concerted effort" of "women, physicians, health officials, researchers and media"?????

Of especial note: a New York 2012 bill would mandate that no pharmacist shall dispense or sell the drug leuprolide acetate, lupron, lupron depot, lupron depot-ped, Viadur, & Eliqard, unless the container is labeled with the following warning - "Caution: this drug could cause adverse reactions included, but not limited to, heart attack, diabetes, convulsions, excessive bleeding, and could lead to death." The disposition of this 2012 N.Y. bill is unclear.

On December 28, 2012 Dr. David Redwine posted on Facebook's Lupron Victims page the following paragraph: "FDA and Lupron: A year ago, I completed a very detailed review of the original studies which brought Lupron to market. The review was based on the studies which were entered as exhibits in the Klein case in Las Vegas in August 2011, although the plaintiff was not allowed to discuss the studies!! I found evidence of systematic 'data management issues' - the raw data did not always support the conclusions. In fact the raw data virtually never supported the major conclusions, but this was glossed over in summary tables and summary discussions, which were probably all the FDA had time and manpower to look at. I sent the review to the FDA a year ago. They have reassured me in emails over the last year that they are looking into my concerns and will let me know when they completed their review. Nothing has happened. A review that a single doctor compiled in 4 months has languished in the bowels of the FDA for over a year. It is time for women who have victims of Lupron to write the FDA and demand toknow what is happening with this review. Martin Kaufman is the person at the FDA who has been corresponding with me. His email address is: Martin.Kaufman@fda.hhs.gov. I have contacted my Oregon US Senators, and have given them the information in the review and asked them to prod the FDA, but only one of them wrote back ... [addendum by Dr. Redwine on same page at "3-19-13" states:] Mr. Kaufman at the FDA ... said that my review had undergone extensive primary review and was now undergoing secondary review and it would be a few more months" ... David Redwine, M.D. Bend Oregon.

In fact, Dr. Redwine's 'Review' of the raw data from the endometriosis clinical trials revealed a very troubling analysis. In one example of fraudulent data and altered outcomes, Dr. Redwine found the raw data indicated "62.5% of women had not regained baseline estrogen levels one year after stopping Lupron ... This is definitive evidence of long-term damage to ovarian function." (For further info, see p. 26 in amicus curiae for US Supreme Court in the Klein case). Since the '90s, reports have accumulated describing young women who, after lupron, experienced premature menopause, ovarian failure, and infertility. Lupron's manufacturer claims in Lupron's label that the Lupron-induced hypoestrogenism (low estrogen) "is reversible on discontinuation of drug therapy."

Almost a year later, on November 13, 2013, the FDA finally responded to Dr. Redwine's 300-page report (entitled "Leuprolide - the 'D' is Silent") - and the FDA determined "no regulatory action is needed", and made no mention of the issue of fraudulent data and altered outcomes. In March 2014, 'Lupron Victims Hub' sent an Open Letter to FDA asking specific questions, which remain unanswered to date.

As the FDA fails to investigate or take action on behalf of public health, the consumer should take note that Lupron, and all GnRH analogs/agonists (aka "relins"), are synthetic versions of the natural, native GnRH molecule (produced by the hypothalamus), but with *UNnatural* amino acid substitutions at various positions in the GnRH molecule. These substitutions cause the analog to be far more potent than the original GnRH molecule. (And bear in mind the relatively newer "GnRH antagonists" are an even further modified molecule than the GnRH agonists/analogs.) As indicated in 1984 by FDA physicians (ie, Gueriguian et al.): 'tinkering' with substitutions in the native GnRH molecule raises long-term safety issues for human health. (For further information on the risks of GnRHa's, see "Section 5: Impact of Lupron [GnRHa's] Upon Women's Brains, Bodies, and Bones" (pages 14 - 17) in my '03 congressional testimony.) It is not clear why, in 1984, issues of long-term safety were an identified issue with FDA scientists - but in 2013, when provided with evidence of fraudulent data and evidence of harm to human health ("62.5% of women failed to return to baseline estrogen levels one year after stop of study - inducating ovarian failure"), the FDA has no comment. When the FDA fails to investigate or take action on behalf of public health - where does one then go?

This website - while providing information, background, and adverse events specifically related to the GnRHa "Lupron" - also contains considerable information on the risks of GnRHa's in general. Do not assume that because you've been prescribed or taken a GnRHa 'other than Lupron' that the information within this website or the adverse events attributed to Lupron should not concern you. All GnRHa's have an adverse event profile - i.e., see the following reports from 'EudraVigilance' (the central database of reports of suspected adverse reactions for all medicinal products authorized in the European Economic Area): Triptorelin, Goserelin, Buserelin, Histrelin, Nafarelin, Leuprorelin. ('EudraVigilance' was set up in 2001, and the data provided here is for reports through November 2012). See also searchable databases: OpenVigil, Canada Vigilance Adverse Reaction Online Database and Australia Database of Adverse Event Notifications.

Over the years I have heard and read reports of health complaints following the use of 'other than lupron' GnRHa's, but the quantity of these complaints has been dwarfed by the volume of complaints about lupron. I have heard from women who have said "I wish I could start a Synarel victims website", and another "would have liked to start a Zoladex victim website" (per wife of prostate cancer patient), and another woman recently wrote that she "would like to start a Trelstar/GnRHa victims website".

Because Lupron/leuprolide has had the largest market share and is the most widely prescribed GnRHa, Lupron/leuprolide therefore has the most reported adverse events and the most public 'profile'. (And lupron is "expected to lose patent protection in 2015", therefore Abbott "will look to replace Lupron in the Ob/Gyn market with" a GnRH antagonist.) But when considering Lupron's adverse events profile, it should be emphasized that "[i]n an article in the Journal of American Medical Association, then FDA Commissioner David A. Kessler revealed that 'only about 1% of serious adverse events are reported to the FDA'." (Moore, Thomas J. Prescription for Disaster: The Hidden Dangers in Your Medicine Cabinet. New York. Simon & Schuster, 1998). And a 2000 GAO report (see page 6) noted that "FDA's AERS [Adverse Events Reporting System] includes an estimated 1 to 10 percent of adverse reactions ... the adverse events that are reported are unlikely to represent the much larger number of unreported events."

Therefore about 90% to 99% of serious adverse events are never reported to the FDA.

 

**********************************************************************************

For "Introduction" to this WebSite, please scroll down to bottom of page ...

**********************************************************************************

||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

NOTEWORTHY NEWS / ACTION ALERT:

|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

09-01-16: Lupron Side Effects Survey Results: Part One, by Chandler Marrs, PhD

08-09-16: Nightmare on Lupron Street, by Lynne Millican, RN. For additional info, see also:

07-16-16: 'Universal Disregard of NIOSH Precautions During Handling, Preparing, and Administering the "hazardous drug" Lupron/leuprolide', by Lynne Millican, RN.

March 2016: Harvard / Brigham & Women's Hospital ScDs published an article (in the journal 'Circulation Cardiovascular Quality and Outcomes') based on 'Nurses' Health Study II' data, associating endometriosis with an increased risk of coronary heart disease - however Lupron/GnRHa use was NOT factored into data/conclusions. See article and Lynne Millican's comment (published April 26, 2016): "Article's conclusions seriously flawed without data on Lupron/GnRHa use" . The authors' reply to Millican's comment contained seriously inaccurate information on Lupron and erroneous conclusions about Lupron's use (see authors' May 11, 2016 response). Subsequently, Millican submitted a detailed, corrective comment to the journal on May 26, 2016, however the journal has apparently declined to publish these corrections (in essence, imo, censoring correct information). Therefore Millican's corrective censored comment is being published here fyi.

11-04-15: Leuprolide 14-day kit Shortage, Leuprolide acetate shortage (lucky are those who could not access leuprolide!)

10-12-15: American Surrogate Mom Dies

10-01-15: UnitedHealthcare Services - "Pubertal suppression therapy (Lupron) is considered unsafe in managing children and adolescents with gender identity dysphoria"

09-16-15: "Restoring Study 329" - a re-analysis of Paxil study data reveals opposite of published study "results". (THIS TYPE OF RE-ANALYSIS NEEDS TO HAPPEN re: LUPRON CLINICAL TRIAL DATA.)

05-11-15: 'Terry Paulsen vs. Abbott Labs, Takeda, TAP' lawsuit filed in Northern District of Illinois. Case No: 1:15-cv-04144.

03-17-14: 'Lupron Victims Hub' sends Open Letter to FDA (remains unanswered to date).

11-13-13: FDA responds to Dr. Redwine's 300-page report ("Leuprolide - the 'D' is Silent"), and FDA determines "no regulatory action is needed"

04-22-13: "Intracranial hypertension in a patient preparing for gestational surrogacy with leuprolide acetate and estrogen"

04-19-12: 41 year old woman - "Lupron-induced dementia" .... "cannot sue"

04-14-13: UK - "There are unsettling stories, shared on internet message boards, that medics themselves don't allow their wives or partners to undergo this invasive fertility treatment because of the health risks involved. ... [3 months after IVF attempt, this woman continues to experience] weeping fits, depressive episodes, acne, weight gain, greasy hair, night horrors and severe abdominal pain."

03-28-13: Florida Egg Donor Suffers Stroke, Sues Fertility Doctor and Egg Donor Agency

03-05-13: Lupron use in autism = "dangerous prescription", "controversial", "Junk science"

02-24-13: Waltham, MA - Pharmacy orders voluntary recall of Leuprolide and Progesterone shipped over last 3 months

rec'd December 2012: Takeda study on 'depression/suicide and GnRHa use' ... I have rec'd a copy of the communication from MHRA (Medicines and Healthcare products Regulatory Agency, in the UK [which, like FDA, receives fees/funding from the pharmaceutical industry - see #8 here]) sent to a European woman (who has suffered gastric and neurological sequelae post-Trelstar), in which information was requested on a study conducted by Takeda on 'depression/suicide and GnRHa use'. This MHRA letter states: "A copy of the [requested] information, which can be disclosed, is enclosed. Please note this document has been redacted and the results of the study requested are exempt under Sections 43 of the Freedom of Information Act and are therefore withheld. We believe that disclosing the information subject to section 43 is not appropriate because such disclosure would be prejudicial to commercial interests. We have considered the balance of public interest with regard to the information withheld, and have concluded that the general bias towards transparency contained within the Act, does not, in this instance, outweigh the potential prejudice to commercial interests." (emphasis mine). 'See' the 2010 "enclosed", "disclosable", "redacted" Takeda study on 'depression/suicide and GnRHa use'. See also 'FLASHBACK':

FLASHBACK: 03-22-12: European Medicines Agency - Pharmacovigilance Working Party (PhVWP): "Following reports of severe depression including suicide from a Japanese survey and a further epidemiological study in the UK, the PhVWP conducted a review of gonatropin-releasing hormone (GnRH) agonists and the risk of depression. The PhVWP concluded that the risk of depression and mood changes should be mentioned and warnings should be included, in a consistent manner and for all indications, in the product information of all medical products in the EU containing a GnRH agonist." (emphasis mine) ... (And please Note - it is standard practice to prescribe antidepressants/SSRI's if depressed/suicidal on lupron/GnRHa's ... see "SSRI Stories - Antidepressant Nightmares" and "Confirmed: Heart problems linked to SSRI's").

12-06-12: Faith Haugh, World's best egg donor succumbs to liver cancer. Dead at 42 years old, she had undergone 42 ovulation induction cycles (which utilize GnRHa's) to produce eggs for infertile couples.

11-06-12: "[In the past] Urologists could make $5,000 per patient dispensing Lupron in their offices, thanks to secret discounts and kickbacks from drug makers [TAP] ... In 1997 the 25 top-prescribing Lupron urologists each averaged $1.6 million in Medicare payments .... Two of every five patients who received hormone therapy didn't need it, the [New England Journal of Medicine] study found. In 2005, after Medicare cut Lupron and Zoladex payment rates by over half, inappropriate use plummeted 44 percent ... Hundreds of thousands of men were chemically castrated for no reason; that's the biggest scandal of all ... The money was too irresistible."

10-04-12: Re: lupron's use in 'treating' Autism - "dangerous, abusive, and exploitive". "There's been no evidence that [lupron] has worked on anybody. This is not somethng that you would want to try without very careful controls and real good evidence."

10-01-12: "[R]esearchers found a 26% increase in risk of birth defects among ART babies", and the pooling of results from many studies found a relative increase in risk of birth defects of 30% - 40%.

10-01-12: New York/NICHD: First large population-based study in US to look at neurodevelopmental effects of ART and its drugs - studying the cognitive, growth, motor, and social development of ART children from birth through 3 years. See Upstate New York Infant Development Screening Program

09-15-12: German study conclusion: "There is a strongly increased risk for anorectal malformations among children born after ART [Assisted Reproductive Technologies]. Elevations of risk were seen after both IVF and ICSI. ... An increased risk of anorectal malformations was also seen among both singletons and multiple births." [Note: few studies identify the names of the 'fertility drugs' utilized in the ART cycles. Please also see top left: "Leuprolide = Reproductive & Developmental Toxicant"]

(03-22-12): European Medicines Agency - Pharmacovigilance Working Party (PhVWP): "Following reports of severe depression including suicide from a Japanese survey and a further epidemiological study in the UK, the PhVWP conducted a review of gonatropin-releasing hormone (GnRH) agonists and the risk of depression. The PhVWP concluded that the risk of depression and mood changes should be mentioned and warnings should be included, in a consistent manner and for all indications, in the product information of all medical products in the EU containing a GnRH agonist."

(January 2007) - Chronic intestinal pseudo-obstruction DUE TO buserelin-induced formation of anti-GnRH antibodies. (buserelin is a "GnRH agonist", as is lupron).

09-03-12: Dr. Khatri - "[M]any side effects of hormones used during IVF can be attributed to Lupron [a "GnRHa"]. ... Lupron has not been approved by the FDA for use in IVF. The drug has been associated with deleterious effects like liver disorders, joint aches, pain in bones, muscle and bone loss, and even memory loss in certain cases." ... Dr. Khatri and others should take note of several early studies involving memory loss and leuprolide/GnRHa's. Dr. Varney's study found "a substantial majority [72%] of the patients showed difficulty with memory while on leuprolide acetate." Dr. Newton's study found that 75% of women experienced memory problems on a GnRHa and "memory disruption may be a more common side effect of GnRHa treatment than currently is recognized", and this study also found that 11% of women (with no prior memory complaints) continued to report memory problems 6 months after stopping the GnRHa. It should also be noted that Dr. Varney stated "there was no correlation between estradiol levels and test results", and Dr. Newton stated "the mechanism by which memory is affected remains unclear." And, in fact, these 2 studies showed that if a woman did *not* experience memory loss after exposure to leuprolide/GnRHa - she was in the MINORITY.

FDA Reports for November 1997 through August 2012: 1,526 Deaths (including 13 year old).Data, including number of deaths, for period of April 1985 through October 1997 are NOT available.

07-16-12: "A recent inquiry into maternal deaths in the United Kingdom found that OHSS [ovarian hyperstimulation syndrome] following high-dose IVF [consisting of lupron] is now one of the leading causes of maternal mortality in England and Wales. But it may not be the only complication. ... Thousands of women have reported adverse reactions [to lupron]. ... Considering the number of women who've taken these drugs over the past 25 years, you'd think much more rigorous studies and analysis would have been done."

07-12-12: India - 17 year old egg donor dead. ... Note the following comment by Kathleen Sloan, feminist leader and human rights advocate (who mentions risks of lupron): "How many more women will have to die before India and the United States ... take action? No country can claim to respect women's human rights while simultaneously turning them into commodities subject to life-threatening harms."

06-15-12: "Miscarriage of Justice" - "Deeply Disturbing" ... Amicus Curiae brief of Consumer Attorneys of California (CAOC) supporting Karin Klein v. TAP/Abbott/Takeda and supporting reversal was filed. Entire Amicus brief can be found here. The following are pertinent excerpts from the Amicus: " ... [TAP/Abbott/Takeda] do not consent to CAOC's participation ... CAOC examines, in particular, the abuse of discretion standard of review. ... district courts may not simply "do as they please." ... the district judge's evidentiary rulings are at loggerheads with substantive law deeming admissible the very evidence (other Lupron warnings) she sought to present - yet never seen by the jury. ... A district court going down this path 'by definition abuses its discretion." ... There is no polite way to characterize the proceedings below. With all respect to the district court, the trial and discovery skirmishes preceding it were a miscarriage of justice. This is the rare case where, for the reasons Klein has identified, this Court should reverse for a do-over. ... Klein got to a jury, only to be entirely shackled in the evidence she was allowed to present. It is particularly galling to have qualified (and expensive) expert witnesses on hand to testify, only for them to be shut down before the jury and precluded from offering competing expert opinions. The pattern shown by the record is deeply disturubing. Virtually every discovery and evidentiary ruling, and other orders of significance, went for one party [TAP/Abbott/Takeda]. Klein was not entitled to a perfect trial, but at least an evenhanded one. Such a one-sided proceeding was not the fair trial our system demands. ... The sum of Klein's evidentiary presentatin was entirely, and erroneously, kept from the jury. This should more than suffice to reverse for a new trial."

06-06-12: Appeal filed in Klein v. TAP/Abbott/Takeda.

05-24-12: Study - Young women having IVF treatment at 'higher risk of breast cancer' - "Women who have IVF in their twenties are up to 50 per cent more likely to develop breast cancer." (see post below dated 10-17-11 for more information)

05-14-12: "IVF clinics accused of putting money before safety" - Professor: "There is no doubt that women subjected to the kind of stimulation [which includes lupron/GnRHa's] are at serious health risk and yet the HFEA appears to hide behind a confidentiality clause when it comes to releasing clinical complications." Confidential inquiry in UK showed "OHSS was now one of the biggest causes of maternal mortality in England and Wales."

05-13-12: "OHSS now one of the biggest causes of maternal mortality in England & Wales."

05-01-12: Event on May 1 ... Showing of 'Eggsploitation', at Stanford. Award-winning documentary 'Eggsploitation', which "blows the whistle on the deceptive practices of the infertility industry to exploit young women for their eggs", will be shown at Stanford on May 1. 'Eggsploitation' has now been shown in over 20 countries. The risks of lupron associated with egg donation and fertility 'treament', IVF, are discussed in 'Eggsploitation'. (See posts below, dated 10-13-11, 09-22-11, & 04-06-11, for further information). The Stanford Daily reports on the event - 'Panelists discuss egg donor risks'.

04-26-12: Teen Endometriosis ... The "diagnosis of endometriosis cannot be made by determining the response to empiric therapy (such as Lupron), but rather by seeing the lesions and getting histological confirmation of the diagnosis".

04-26-12: In Re: Lupron Marketing & Sales Practices Litigation - law firm says "clients plan to petition the U.S. Supreme Court for certiorari." For original August 6, 2010 Memorandum & Order In Re: Lupron Marketing & Sales Practices Litigation, see here.

04-24-12: In Re: Lupron Marketing & Sales Practices Litigation - US Court of Appeals has affirmed the decision of the US District Judge to allocate the 'surplus' $11.4 million to Dana Faber / Harvard Cancer Center and the Prostate Cancer Foundation to study "lupron-treatable diseases" (instead of distributing the funds to lupron purchasers, lupron victims, &/or the 'Consortium'). As I wrote to the Judge in May 2009: " Please tell me what purpose did the $100 remuneration awarded to claimants in this case serve, since the Lupron victim is overwhelmed with acute and chronic symptoms, illnesses and diseases, and has perpetual doctor, dentist, pharmacy, and hospital bills, and this status quo will exist for the rest of their ruined lives? When one overpays for a poison, the law and the justice system should be concerned not just with investigation and prosecution for the 'overpayment' - but exposure and resolution of the poisoning MUST take place, or our justice system is a farce, and is as harmful as a vial of Lupron has been to its victims." -------- Of note in the above litigation's decision is the statement that the judgment of a trial judge would be found seriously lapsed if, for example, "the decision ignores a material factor deserving significant weight". ..... What, IF ANY, "weight" was given to the following material facts? - There exists thousands of lupron VICTIMS ("10,000+" as of the year 2000, per the NLVN), and they suffer post-lupron from irreversible, costly - and NON-INVESTIGATED - iatrogenic health sequelae; compounded by marginalization and a lack of medicolegal advocacy. As stated to the Judge in my May 2009 letter: "It is nothing short of a travesty of justice that the Lupron victims, amidst all this pricing litigation, have been effectively and silently swept under the rug." (See post below, dated 02-28-11, for further information). Mass Lawyers Weekly reports: "No abuse of discretion has been shown and as a result the distribution order should be affirmed."

04-24-12: Study: "IVF drugs linked to childhood cancer." French researchers "believe there is an association between the use of ovarian stimulation drugs and 2 types of childhood leukemia." ... Note: ovaian stimulation, IVF and assorted ART (Assisted Reproductive Technologies) procedures involve multiple 'fertility drugs' - of which lupron is "commonly prescribed".

04-04-12: Study - Early heart disease risk associated with IVF, assisted conception. "ART [Assisted Reproductive Technologies] induces generalized vascular dysfunction in ... young apparently healthy [IVF] children". ART cycles utilize 'fertility drugs' - of which lupron is "commonly prescribed". This study raises the question whether "the drugs used to stimulate ovulation may have adverse effects on the outcome of the offspring." In another article on this study, it is mentioned that "[o]ther research has recently also found elevated blood pressure and blood sugar levels in IVF offspring."

04-03-12: Study - "Children conceived by IVF &/or ICSI are at significantly increased risk for birth defects." - finding a 37% higher risk of a birth defect across a range of body system. In this study, the question is also raised whether "the IVF techniques themselves, the jostling and handling of the embryos, or the drugs that go along with the fertility treatment" are involved.

03-27-12: I've rec'd communication from a physician who is a lupron victim (not the first physician-lupron-victim to contact me), and she has agreed to my reprinting relevant excerpts of her letter publicly here fyi (though she wishes anonymity at this time). Here are her comments:

"Physician falls victim to Lupron" - "Lynne- I am a 41 year old board certified family practitioner who has dealt with debilitating chronic illness since I was 20 yrs old. You know how the rest of this email will read - took Lupron - got sick and now my life is in ruin. The saddest part is until 1 wk ago when I came across your website I thought all my odd medical problems were all just coincidence!! Thats the horror of what has happened to me - is that I had NEVER put together the common thread of LUPRON! I thought Lupron was helping the FIVE times I have used it! ESPECIALLY because I am a physician. Yes I can get sick just like everyone else BUT you think I'd have put the pieces of the puzzle together BUT I trusted what was printed in Lupron's inserts and studies! Mistake I'll be paying for the rest of my life! ... I had developed Inappropriate Sinus Tachycardia (heart rate stayed 120-150 24hrs/day 7 days/wk!) ... Autonomic Dysautonomia ... THREE 12-13 hour cardiac ablations ... pacemaker ... on strong pain rx for pain management for life. In 2002 I was total and permanently disabled ... SEVERE sleep apnea: Obstructive and Central sleep apnea (again no good reason why my BRAIN is not giving signal to breathe??) ... I continued to be in the hospital with bowel obstructions, severe pain limiting every move I made ... nausea and vomiting, pain have gotten worse and I've now found out that I have GASTRIC PARESIS. ... From what I have read, it sounds like so MANY corners were cut by FDA getting Lupron approved ... but what a TRAGEDY that those cut corners have caused such huge damage and destruction in young women who had such bright futures - just like me! ... I barely have energy to get out of bed most days ... I would give anything just to have some quality of life again. ... Something has to be done."

03-22-12: European Medicines Agency - Pharmacovigilance Working Party (PhVWP): "Following reports of severe depression including suicide from a Japanese survey and a further epidemiological study in the UK, the PhVWP conducted a review of gonatropin-releasing hormone (GnRH) agonists and the risk of depression. The PhVWP concluded that the risk of depression and mood changes should be mentioned and warnings should be included, in a consistent manner and for all indications, in the product information of all medical products in the EU containing a GnRH agonist."

02-21-12: Guilty plea in lupron drug diversion scheme

02-15-12: Lupron Depot 3.75 mg & 11.25 mg Safety Labeling Changes: hepato-biliary disorders.

01-27-12: Law firm "wants to ensure that the dangers of Lupron are well known", and puts YouTube video online.

11-07-11: 3rd Connecticut hospital this year settles allegations (paying $471,933) involving improper billing to Medicare for lupron injections.

11-03-11: Teenager, "a different person ... unable to remember things or focus" on lupron, finds relief for endometriosis through CO2 laser excision surgery.

10-27-11: Dutch Study: Fertility treatment raises tumor risk - Women given fertility 'drugs' found to "have an increased risk of developing borderline ovarian tumors." Research is from data from the OMEGA study, involving 19,146 subfertile women treated with IVF and 6,006 subfertile women not treated with IVF, from twelve IVF clinics in the Netherlands between 1980 - 1995: "For ovarian malignancies overall and for borderline ovarian cancer, there was a 2- and 4-fold higher risk, respectively, in the IVF treatment group compared with the subfertile group not treated with IVF." Additional articles linked here. Lead researcher states: "Our data clearly show that ovarian stimulation for IVF is associated with an increased risk of borderline ovarian tumors and this risk remains elevated up to more than 15 years after the first cycle of treatment." "Patients may be advised to limit [IVF] treatment cycles". (Note: Gilda Radner, of SNL fame, died of ovarian cancer after unsuccessful fertility treatment ... in her book 'It's Always Something', Gilda questioned many things as possibly causing her ovarian cancer [i.e. hair dyes, red meat] but never thought to question the fertility drugs she took). Of note, the CDC does not list fertility treatment/drugs as a risk factor for the development of ovarian cancer. ... Informed consent to these drugs cannot be given without substantive data and an analysis of same. Large-scale, epidemiologically sound, long-term studies of the risks to women and offspring from lupron and other fertility drugs remain lacking - therefore the "informed consent process" is inherently flawed, and as such, is a misnomer. Caveat emptor!

10-25-11: Dr. in case regarding Senator says lupron's "side effects include forgetfulness & loss of reasoning ability ... 25 - 30% experience some cognitive effects ... they forget things ... they get lost driving ..." See related story (09-26-11) - Lupron "reduced senator's cognitive abilities and made him 'fuzzy'" (Note: In one study of leuprolide's use in women undergoing IVF, it was found that 72% [seventy-two per cent] of the women experienced difficulty with memory ["a commonly observed complaint"]; and in another study of GnRHa use in IVF, 11% of the women continued to complain of memory loss 6 months after stopping the GnRHa: - see 'NLVN' page "Memory Loss & Cognitive Dysfunction" for further information. ... In fact - if a woman does *not* experience memory loss from lupron, she is in the Minority! See also ERC 2003 Survey (linked at left, below) evidencing that 23.33% women surveyed suffered lasting effects for up to 5 or more years after stopping lupron.)

10-23-11: UK "Human Egg Farms" - women superovulated to produce up to 85 eggs at one time.

10-17-11: "Controversial Therapy" for pre-teen transgender patient raises questions - "potential long-term effects can include other abnormalities of hormones, vascular complications and even potential cancer." Another similar story: Lupron Depot to "pause the child within". Psychiatrist calls Lupron treatment "a modern form of child abuse". ... While 'treatment' with lupron is touted as "saving kids the anguish of ... everything from depression ... to suicide" - no one seems to address the fact that lupron has been reported to have *caused* everything from depression to suicide! (i.e., See 'AERS', 'Risks', 'Deaths', and 'NLVN' pages)

10-17-11: Celebrity undergoes several unsuccessful IVFs, and announces has breast cancer. Giuliana Rancic, of the TV show 'Bill & Giuliana' (who reported having 63 hormone shots a month during IVF last year), appeared on the 'Today Show' to tell "a pretty amazing story" of how lucky she was to have been undergoing IVF because in doing so her breast cancer was detected - and she is "not going to give up on trying to have a[n IVF] baby". Is there a connection between Giuliana's breast cancer and her IVF drug 'treatment' (which could, but may not, include lupron)? US experts discount a causal connection as "probably unrelated ... studies [are] virtually inconclusive" . UK's Medical Director states "many breast cancer specialists now suspect that there may be a link between breast cancer and IVF" and the UK offers pre-IVF breast screenings. Liz Tilberas publicly blamed her breast cancer on the fertility drugs she took . Two UK women likewise were convinced their breast cancer was triggered by IVF. (Flashback: December 2010 Elizabeth Edwards dies of metastatic breast cancer, several years after undergoing IVF). There are other internet references to breast cancer development after IVF drugs where women make absolutely no mention of causality between IVF/fertility drugs and development of cancer - such as here and here. In studies, "borderline-significant increased risk of breast cancer" have been noted. (See also here and, also see 09-22-11 below re: the fertility industry's reaction to the alarming message of the award-winning documentary 'Eggsploitation'). Of note - the CDC does not list fertility treatment/drugs as a risk factor for the development of breast cancer. ... Informed consent to these drugs cannot be given without substantive data and an analysis of same. Large-scale, epidemiologically sound, long-term studies of the risks to women and offspring from lupron and other fertility drugs remain lacking - therefore the "informed consent process" is inherently flawed, and as such, is a misnomer. Caveat emptor!

10-13-11: Jennifer Lahl responds to "verbal mauling" by US fertility doctor reacting to her presentation on the risks to women of the drugs/process of egg donation (see 09-22-11 below).

09-22-11: Canada Fertility & Andrology Society (CFAS) conference - "What the IVF industry is doing is creating a population of sick babies ... that is impacting all society." (Reference is to adverse effects of multiple births - the effects of fertility drugs [i.e. lupron] is not mentioned). During the same conference, but at a separate session, Jennifer Lahl, RN, & her award-winning documentary 'Eggsploitation' are "verbally eviscerated" by a US fertility doctor. (Lahl's documentary film 'Eggsploitation' *does* address the risks of fertility drugs [including lupron] to egg donors & fertility consumers). The US doctor, following his "verbal mauling", received a robust & enthusiastic round of applause from the audience of 200 fertility doctors. Instead of addressing the risks to women of drugs used for superovulation (i.e. lupron), the doctor descended into attacks of Lahl's faith! ... (And what, pray tell, does one's faith have to do with the FACT that women are - and have been - reporting serious health problems after undergoing egg donation & IVF???)

09-22-11: In another CFAS session, Geneticist Dr. Weksberg found "IVF babies up to 10 times more likely to suffer rare genetic disorders" (specifically Beckwith-Wiedemann Syndrome [causing unevenly sized limbs, enlarged tongue, and high risk of kidney tumors {found in 1 out of 1,300 fertility-treatment children vs. 1 in 13,000 in general population}] and Angelman Syndrome [causing serious mental retardation and speech impairment {found in 1 out of 1,500 fertility-treatment children vs. 1 in 15,000 in general population}]) ... and Dr. Weksberg "would like to partner with fertility clinics to study large populations of fertility-treatment children, but has NOT BEEN ABLE TO FIND ANY WILLING TO WORK WITH HER ... there was an apparent LACK OF INTEREST from Weksberg's audience [of fertility doctors] for her speech ... very telling." Dr. Weksberg opines that these genetic disorders are "likely a combination of infertility problems and genetics, and THE TREATMENT THEMSELVES." .............. (Emphasis in quotes are mine ... And just Why is there NO emphasis or interest by fertility doctors? - Perhaps someday somewhere somehow someone will think to look into lupron/leuprolide's designation and role as a "Recognized Reproductive and Developmental Toxicant" and ponder WHY lupron/leuprolide is "commonly used" [since the 1970's] to superovulate women throughout the world [despite Abbott's discontinuation of lupron/fertility/IVF studies and lupron's non-FDA approval for the indication of superovulation] - just a thought.). .............. Of note are recent concerns of UK researchers that identified "the pattern of genetic errors leading to Down's in IVF eggs [of women over 31 years of age] was different & more complex [than those that are conventionally age-related] ... this led researchers to believe that it was the fertility treatment that was to blame. ... we already know that these fertility drugs can have similar effects in laboratory studies." (see 'Risks' page - "Babies / IVF" for further related info)

09-21-11: Jury verdict in Klein v. TAP has been appealed. Case 2:08-cv-00681-RLH-RJJ - Document 310.

09-21-11 posted on YouTube: Part 6 (#1) by Darcy Spears: Lupron Trial, Plaintiff Outraged by Severe Injustice, and Part 6 (#2) Lupron Trial, Plaintiff Outraged by Severe Injustice. (See 'Media' page for additional links)

08-24-11: First reported case of leuprolide-induced severe rhabdomyolysis and renal failure, accompanied by (the second reported case of) inflammatory myopathy in a prostate cancer patient.

08-10-11: Lupron verdict in Las Vegas trial deals blow to victims. (This KTNV newslink is posted belatedly on 08-13-11 because, for the 52nd time since 2003, I was hospitalized due to severe gastroparesis post-lupron. Karin Klein, myself, and tens of thousands of others have suffered and will continue to suffer from the damaging and disabling effects of lupron/leuprolide. Perhaps someday a judge will want the jury to know this.) The plaintiff has until September 21, 2011 to appeal. (see 'Media' page for KTNV's 7-part series)

08-01-11: The FIRST lupron lawsuit scheduled to go to TRIAL ('Klein v. TAP/Abbott', in Nevada) begins on 08-01-11 with jury selection. All other prior lupron lawsuits to date have been settled out of court, with secrecy agreements ("gag orders"). 'Klein v. TAP/Abbott' is scheduled for trial. See: "Trial for 'Overpriced Poison' Lupron begins in federal court" - Judge will not allow the admission into evidence of any former U.S. lupron labels, foreign labels, warnings in PDR, scientific journals, MedWatch forms (adverse event forms), or any information related to TAP's pleading guilty to a felony.

Follow 'Klein v. TAP/Abbott' on Twitter. See DeLuca & Nemeroff' lupron page. Watch DeLuca & Nemeroff's video: "Lupron health dangers for Lupron victims".

Read 'Klein v. TAP/Abbott' Medical Expert Witness Statement by Dr. David B. Redwine describing TAP's lupron "medical fraud" as being "the most egregious example of Big Pharma controlling the practice of medicine". Dr. Redwine concludes that lupron is "unsafe and harmful in addition to being ineffective". The enticements offered to doctors by TAP to promote and prescribe lupron are illustrated - Dr. Redwine details TAP's offer of $100,000 in exchange for prescribing lupron to his patients. Dr. Redwine also comments on his experience with approximately 750 patients who have taken lupron/GnRHa's (mostly lupron) and who report and manifest adverse, lingering symptoms. (See confidential TAP memo detailing the $105,011.40 annual 'pay' doctors could earn if they prescribed lupron to their patients. This internal TAP memo, disclosed during Commerce Committee hearings in 2000, illustrates Dr. Redwine's experience.)

In 'Klein v. TAP/Abbott', Dr. John L. Gueriguian, former FDA Medical Officer, states in a prepared report the following expert opinion: "Lupron causes irreversible side effects and permanent severely disabling health problems. ... TAP intentionally suppressed knowledge about the real dangers associated with the use of Lupron. ... Prescribers and patients were misled. ... In fact, Lupron causes irreversible damage to the human body and the development of chronic disabling diseases. ... TAP fails to warn about hazards associated with the use of Lupron. ... Lupron Depot is both ineffective and unsafe ... Lupron appears to be more toxic than other GnRHa's ... [Plaintiff] presented with chronic disabling health problems ... showed signs of precocious ageing ... Lupron had wrought debilitating adverse events and had caused chronic and apparently permanent health problems. ... A great number of individuals have come forth to describe the same or similar problems and the medical literature now supports their claims."

07-28-11: Illinois latest state to launch investigation into Dr. Mark Geier's lupron/autism 'treatment'. ... 05-04-11: Dr. Mark Geier loses license to practice medicine in Maryland because he "endangers autistic children ... by administering ... a treatment protocol [lupron] that has a known substantial risk of serious harm ...". Dr. Geier also lost his license in Washington state, a month later (and other states may follow).

07-25-11: The anniversary and health of the world's first IVF birth, Louise Brown's 7-25-78 birthday, is celebrated once again. What is rarely mentioned is the fact that Louise Brown's mother underwent IVF using NO fertility drugs WHATSOEVER ("natural cycle IVF") - unlike nearly all of the world's subsequent IVF cycles which heavily utilized fertility drugs to maximize egg production.

June 2011: Revised label for Lupron 3.75 mg

04-06-11: Award-winning documentary, 'Eggsploitation', was shown at Boston College Law School. Risks of lupron, and the lack of data-tracking of women who undergo egg donation and IVF, were discussed. 'RESOLVE' (the organization that alleges to "educate, advocate, and support the infertile") had in attendance a Board Member who attempted to discredit 'Eggsploitation' as "biased" and 'not representative of the industry'. 'RESOLVE's' Board Member failed to inform the audience of 'RESOLVE's' conflicts of interest: RESOLVE has a history of receiving hundreds of thousands of dollars from the fertility drug manufacturers, fertility clinics, and fertility doctors.

03-16-11: S 6811 - NY Senate enacts law to take effect Jan 2012: No pharmacist shall dispense or sell the drug leuprolide acetate, lupron, lupron depot, lupron depot-ped, Viadur, & Eliqard, unless the container is labeled with the following warning - "Caution: this drug could cause adverse reactions included, but not limited to, heart attack, diabetes, convulsions, excessive bleeding, and could lead to death."

02-28-11 - Deadline for Letter of Intent for Researchers: $11 million, initially dedicated to plaintiffs in the lupron settlement case (see 12-23-10 below), has instead been allocated to Dana-Farber/Harvard Cancer Center. The "'Lupron-Treatable Disease and Conditions Awards' will support investigators who are focused on non-Prostate Cancer diseases and conditions that are Lupron-treatable, including but not limited to endometriosis, uterine fibroids, and precocious puberty .... Projects may focus on [among others] medical decision analysis, survivorship and quality of life ..." ------------- QUESTION: Will these researchers be focused on the "medical decisions, survivorship and quality of life" related to the disease(s) being "treated" with lupron - OR will these researchers be focused on the "medical decisions" surrounding the prescription of lupron, and the survivorship OF lupron, and the quality of life POST-lupron??? This question is crucial!

02-14-11: Anonymous Pharmaceutical Insider Speaks on 'CafePharma' Message Board (@ "3:23 pm" - at bottom of page): ... "The 6 month dosage of Lupron will KILL patients. That's being illegally marketed AGAIN for IVF, and Abbott made the Wall Street Journal 3 times in 1 week (12/10) for illegal marketing of stents and drugs. When will the corruption finally end. It's widely acknowledged that Lupron isn't a cure for anything and does more harm than good." At the same message, another Anonymous Insider posts (on 03-27-10 @ "7:45 pm"): "YOU DUMMY, ABBOTT PAYS MILLIONS UNDER THE TABLE SO DOCS USE LUPRON, WAKE UP YOU MORON ..." (See 'History' page for further relevant 'CafePharma' messages)

02-11-11: An Industry news article, promoting a GnRH antagonist, identifies "Most women shy away from Abbott's Lupron due to side effects."

02-07-11: DOJ intervenes in at least 3 whistleblower lawsuits detailing Abbott's off-label marketing of Depakote. Note: Anonymous lupron sales rep alleges lupron is "being illegally marketed AGAIN for IVF (see CafePharma message on 2/14/11 @ 3:23 pm, at bottom of page). Lupron sales reps need to whistle for real.

02-05-11: eHealthMe 'study' - "238 people reported to have side effects when taking Eligard (leuprolide) - 120 people (50.42%) have Sudden Death" (See also: FDA Warning Letter re: Promotion of Eligard 45 mg)

01-30-11: The documentary film 'Eggsploitation' (in which risks of lupron are discussed) was named "Best Documentary" for the 2011 California Independant Film Festival Slate Awards. (Scroll below to "INFORMED CONSENT" for further information on 'Eggsploitation')

12-27-10: Cataracts added to list of risks from lupron, ADT ... Read abstract of study.

12-23-10: Plaintiffs in lupron settlement funds ignored, and research into lupron victims ignored - Judge awards $11.7 million surplus lupron settlement funds to Harvard Prostate cancer researchers. ... (flashback: 11-16-10: Judge orders dispersement of lupron Class Settlement Funds: First Cy Press Payments to Dana Farber/Harvard Cancer Center ($4,000,000). [Note: the plaintiffs who were awarded the settlement funds are NOT being given the surplus funds])

12-07-10: Elizabeth Edwards dies of metastatic breast cancer. While Elizabeth Edwards did not ever publicly correlate her IVF treatment (lupron presumably used) with the development of her cancer, she nonetheless joins a list of untold women who have developed cancer after fertility/lupron treatment. See a partial, growing list.

11-10-10: Journal of National Cancer Insititute - "Long-term ADT (androgen deprivation therapy [GnRHa's, lupron, leuprolide]) for prostate cancer is associated with an increased risk of colorectal cancer"

10-20-10: FDA Alert: Labeling Changes for Lupron, GnRHa's, for men. Risk of diabetes, heart attack, sudden cardiac death, and stroke must be added to Warnings & Precautions' section of the label. See also January 2011 FDA Safety Labeling Changes for Viadur. (Flashback: 05-03-10: FDA conducting safety review of lupron and other GnRHa's in prostate cancer - preliminary review suggests an increased risk for diabetes and certain cardiovascular diseases in men treated for prostate cancer. Read FDA Safety Review Communication)

[Note re: lupron labeling changes above - Since the '90's, I've tried to make the case that lupron's adverse cardiovascular profile prior to lupron's initial FDA approval was *not* being addressed ...: i.e. see excerpt from my 'USA[ttorney] Draft Document' discussing this issue: 'Was lupron's Initial Approval Based Upon Safety and Efficacy?'. ... "Was lupron shown to have less cardiovascular side effects than DES, a claim that was critical to its approval? ... Is it 'acceptable' to grant TAP's request to withhold {lupron's initial clinical trial} adverse events from disclosure in the initial approval label ... figures which, when tabulated, cast serious doubt upon lupron's alleged 'improved cardiovascular risk profile in comparison to DES'"?]

Read Medical Expert Witness Statement by Dr. David B. Redwine describing TAP's lupron "medical fraud" as being "the most egregious example of Big Pharma controlling the practice of medicine". Dr. Redwine concludes that lupron is "unsafe and harmful in addition to being ineffective". The enticements offered to doctors by TAP to promote and prescribe lupron are illustrated - Dr. Redwine details TAP's offer of $100,000 in exchange for prescribing lupron to his patients. Dr. Redwine also comments on his experience with approximately 750 patients who have taken lupron/GnRHa's (mostly lupron) and who report and manifest adverse, lingering symptoms.

See confidential TAP memo detailing the $105,011.40 annual 'pay' doctors could earn if they prescribed lupron to their patients. This internal TAP memo, disclosed during Commerce Committee hearings in 2000, illustrates Dr. Redwine's experience (above). How many doctors, like Dr. Redwine, refused the $100,000 'offer' and did not prescribe lupron to their patients? How many doctors 'signed-up' for 'the cash' and 'gave' lupron to as many patients as they could frantically find? Why have so many women complained that their doctors were "shoving lupron down [their] throat[s]"? ... (Of note: in my 1992 MA. testimony, I identified that "Nearly every IVF clinic has mandated women take lupron or they will not be allowed to [begin their IVF] cycle ... The use of this drug has become pervasive over a very short period of time, without informed consent ...").

Dr. John L. Gueriguian, former FDA Medical Officer, states in a prepared report (for a female lupron product liability lawsuit) the following expert opinion: "Lupron causes irreversible side effects and permanent severely disabling health problems. ... TAP intentionally suppressed knowledge about the real dangers associated with the use of Lupron. ... Prescribers and patients were misled. ... In fact, Lupron causes irreversible damage to the human body and the development of chronic disabling diseases. ... TAP fails to warn about hazards associated with the use of Lupron. ... Lupron Depot is both ineffective and unsafe ... Lupron appears to be more toxic than other GnRHa's ... [Plaintiff] presented with chronic disabling health problems ... showed signs of precocious ageing ... Lupron had wrought debilitating adverse events and had caused chronic and apparently permanent health problems. ... A great number of individuals have come forth to describe the same or similar problems and the medical literature now supports their claims."

More reports from other experts will (invariably) follow.

09-08-10: "Defective Drugs ... Lupron" (attorney website) - Notice posted by another lawfirm about potential lupron litigation.

08-11-10: Yet Another law firm investigates potential claims against lupron's manufacturer

08-03-10: Re: lupron's dangerous use in autism ... "Lupron carries a risk of bone damage, stunted growth and heart trouble, and can render children impotent ... we cannot be using these children as guinea pigs in a medical experiement ... we have very significant concerns about irreversible damage to sexual function and the brain and sex organs of these children."

Please consider filling out a MedWatch form to report your adverse events.

Read Boston FOX 25 TV News' 1999 2-part investigation of lupron: "Risk or Remedy?" Part 1 (transcript) and "Dangers of Lupron" Part 2 (summary)

03-06-10, "LawyersandSettlements.com" - 'Lupron: Do the Risks Outweigh the Benefits?'

CENSORSHIP: In the future, I will have a page devoted to the issue of lupron and censorship, but for now will post this most recent example: A website promoting the film, 'Journeys, The Art & Science of Making a Baby", had a comment section. Here is a copy of my posted comment. But, as you can see, my comments have been removed from the website. (In fact, it appears that no one can comment now). Why would a film that is allegedly educating women about IVF deliberately censor information about the disabling effects of lupron (as reported by an R.N., a J.D., and an M.D., who each underwent fertility treatment/IVF with lupron and are now disabled)? [Update: the link to the film's website has been removed ... thereby attempting to cause evidence of the censorship to 'disappear'. This M.O. is typical of this 'field'.]

INFORMED CONSENT: In contrast to the above apparent censorship of risks in fertility treatment, see the trailer for 'Eggsploitation' - a powerful documentary film exposing reproductive endoCRIMINology's "dirty little secret" about the serious risks of egg donation (and infertility treatment): www.Eggsploitation.com. The risks to lupron are discussed.

Read statement of 'Options National Fertility Registry' owner Teri Royal concerning the 2009 'Dismissal of OPTIONS National Fertility Registry Class Action Lawsuit' (egg donors rec'd lupron). In OPTIONS Class Action Lawsuit, 669 embryos and 2,140 eggs went UNACCOUNTED FOR. Additional audits of Options' records suggest there were 2,189 eggs unaccounted for, greater than 300 post-cycle reports had irregularities, and these 'irregularities' involved 80 medical facilities, 102 physicians, and 229 egg donors.

Kansas Bill (Senate Bill No. 509): Women's Health & Embryo Monitoring Program (hearing 3/11/10)

Arizona Bills: Relating to Human Eggs and Relating to the Treatment of Embryos

AZ Bill S1306 passed - requiring disclosure of health risks associated with the drugs used in donating eggs ... risks to be detailed. 03-05-10: S1306 expected to go to House next week

Americans United for Life's Model Legislation: Assisted Reproductive Technologies Disclosure & Risk Reduction Act

Fyi, see 'lupron search terms' captured by the daily logs of www.LupronVictimsHub.com, as relayed within my recent letter to the Deputy Commissioner of the FDA. While anectodal, these search terms speak volumes.

Read Rachelle Fenner's 'MY POEM', a heart-wrenching description of life as a lupron victim.

Crock 'O Crap Alert: See PR release state GnRHa side effects "are reversible", bone loss "reversible after treatment stops", fibroids "shrink", bone loss "prevented by use of calcium supplements". These 'assertions' are UNTRUE! Do your homework so you will not be fooled! (Update: Press Release has been removed).

Authorities should take note of the following examples:

-Illegal Infertility Forum post selling Lupron over net: Lupron 14-day kit - $70 (posted 05/12/11)

-Illegal Infertility Forum post selling Lupron: Lupron Kit - New in Box for Sale (posted 02/25/11)

-Illegal Infertility Forum post selling Lupron: (2) Lupron 14-day kits @ $90 each (posted 02/20/11)

- Illegal Infertility Forum post selling Luporn: Lupron, 2 week kit - Make an Offer! (posted 10/23/10)

- Illegal Infertility Forum post selling Lupron: 14 day Lupron kit for sale (posted 7/23/10)

- Illegal Infertility Forum post selling Lupron: Lupron Kit - $90 + shipping (posted 7/20/10)

- Illegal Infertility Forum post selling Lupron: 14 day Lupron kit for sale - $90 (posted 6/6/10)

- Illegal Infertility Forum post selling Lupron: Expired vials of Lupron - Make An Offer (posted 4/28/10)

- Illegal Infertility Forum post selling leuprolide: Leuprolide, 2 Week Kit for sale, $100 (posted 3/17/10)

- Illegal Infertility Forum post selling leuporlide: Leuprolide 14-Day Kit for sale, $90 (posted 3/11/10)

- Illegal Infertility Forum post selling leuprolide: Leuprolide 14-Day Kit for sale, $95 (posted 3/5/10)

- Illegal Infertility Forum post selling Lupron: sale of lupron (posted 2/22/10)

- Illegal Infertility Forum post selling leuprolide: sale of leuprolide 14-day kit for $75 (posted 2/22/10)

- Illegal Infertility Forum post selling Lupron: sale of unopened lupron kit (posted 2/19/10)

- Illegal Infertility Forum post selling Lupron: "lupron 14-day kit for $140" (posted 2/19/10)

- Illegal Infertility Forum post selling leuprolide: sale of leuprolide 14-day kit (posted 2/16/10)

- Illegal Infertility Forum post selling Lupron: "10 pre-filled lupron injections, $15 each" (2/10/10)

- Illegal Fertility Website post selling leuprolide: "Leuprolide acetate 14 day kit for $100" (posted 2/9/10)

- Illegal Infertility Forum post selling leuprolide: Leuprolide 14-day kit for sale (posted 2/16/10)

 

***************************************************************************

***************************************************************************

INTRODUCTION:

This website has been developed to serve consumers, healthcare workers, attorneys, academia, and law enforcement officials seeking information on the GnRHa ‘drug’ Lupron (leuprolide) and its associated health risks.  Also explored will be the problems with lupron’s approval by the FDA, lupron’s history and ‘science’, the marginalization of lupron victims – and, in short … every pertinent thing I’ve learned or written or received regarding the ‘drug’ lupron/leuprolide and GnRHa's since 1989.  Over the course of this time, I’ve accumulated much information and many documents and letters, and I want to put this information in the public domain fyi. 

My exposure to lupron was through ‘treatment’ of endometriosis and infertility (IVF), but those considering or using lupron or other GnRHa's for other indications (such as prostate cancer, fibroids, egg donation, surrogacy, precocious puberty, transgender, autism, Alzheimers, etc.) will find much information within this site that pertains to them (i.e., see LupronSUQS, and 'Risk' page). However, a focus of this site will be upon the risks inherent in reproductive technologies (IVF, egg donation, surrogacy). 

Since taking lupron in 1989, I have experienced multiple health problems. In my career as a registered nurse, my work schedule prior to lupron entailed 40+ hours/week; however subsequent post-lupron medical problems resulted in periods out of work, with a gradual decrease in workhours over the years from 32 to 24 to 16 hours/week; and in 2003 became disabled. From 1992 - 2003, I extensively researched the risks of lupron/GnRHa's throughout Boston area medical libraries, and over the years have tried to bring attention to the dangers of this ‘drug’ through contact with (and delivery of risk information to) state and federal agencies, Congress, consumer groups, attorneys, medical experts, the media, the grapevine, the courts, and drafting legislation - to name a few. And I had the ironic pleasure of spending 16+ hours inside TAP/Abbott’s ‘lupron files’ as an RN/Paralegal during discovery in a 2002 lupron product liability case (settled).  I also worked very closely with the National Lupron Victims Network from 1994 to 2000, when they, their 10,000+ “lupron victims’ surveys”, their website, and all my provided research information - just up and inexplicably disappeared. (See 'NLVN' page for further info).

I have been planning on putting all this information back online within this site for a long time, but have been very sick. Since March 2003, I've been hospitalized 61 times "due to the development of severe gastroparesis post-lupron" - the neurological impulses to my gut have been "paralyzed" by the toxin lupron. (The neurological impulses to my heart have also been affected - recent cardiac monitoring revealed 42 PVCs/minute, including multi-focal PVCs, and I contiue with episodes of bradycardia with heart rates of 38 beats/minute.). Therefore, because of health limitations, repeated hospitalizations, and chronic gastroparesis episodes, this website's debut was greatly delayed and its organization and transition to a more 'reader-friendly' format remains pending. I am just throwing it all 'up there' for anyone that has the need and/or interest to wade through the details.

And this is a 'Work In Progress', therefore please stay tuned ...

Sincerely,

Lynne Millican

 

 

© Copyright Lynne Millican | Home | Risks | Deaths| AERSDocuments | History | NLVN | Lawsuits | Relevant Info | Links | MediaContact