This page addresses DEATHS following the use of Lupron/leuprolide:

Deaths that are reported to the FDA are maintained in an Adverse Event Reporting System (AERS - a.k.a. FAERS) database. These reports are made by filing "MedWatch" forms, and are submitted voluntarily by health professionals and consumers following an adverse event. Send a MedWatch Report to FDA about Lupron/leuprolide Deaths and other Adverse Events.

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12-12-19 ... CALL TO ACTION for Lupron Victims - see 'Media page'.

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DATA from May 2011 through May 2016:

In a May 2016 Freedom of Information Act (FOIA) request to the FDA for updated AERS reports on Lupron/leuprolide, the following data was received:

For the 5 (FIVE) year period May 2011 through May 2016:

Lupron Depot-PED (pediatric use only):

--- there were 39 "total deaths", and there were also 10 "events" listing death. (Per FDA, "Total Deaths" is the number of cases where the stated "outcome" for the patient was death. Typically, death is recorded as an "outcome" and not an "event", unless "death" is the only information that is reported on a case. For this reason, the number "total deaths" is usually greater than the number of coded events of "death".)

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For the 5 (FIVE) year period May 2011 through May 2016:

Lupron Depot (3.75 mg, 7.5 mg, 11.25 mg, 15 mg, 30 mg, 45 mg):

--- there were 962 "total deaths", and there were also 3 "events" listing "sudden death", 3 "events" listing "stillbirth", 1 "event" listing "brain death", and 1 "event" listing "euthenasia". (Per FDA, "Total Deaths" is the number of cases where the stated "outcome" for the patient was death. Typically, death is recorded as an "outcome" and not an "event", unless "death" is the only information that is reported on a case. For this reason, the number "total deaths" is usually greater than the number of coded events of "death".)

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For the 5 (FIVE) year period May 2011 through May 2016:

Lupron (leuprolide, daily injection):

--- there were 151 "total deaths", and there were also 30 "events" listing "death", 5 "events" listing "foetal death", 4 "events" listing "abortion induced", 3 "events" listing "completed suicide", 2 "events" listing "sudden death", and 1 "event" listing "stillbirth".

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Previously requested AERS data is as follows:

As of February 11, 2009, the total tally of reported adverse events to lupron/leuprolide since November 1, 1997, is as follows: 22,667 reported adverse events, with 651 reported deaths from lupron/leuprolide, involving 5,069 individual safety reports. In an online data sample, a graph shows an 'uptick' in numbers of death for the years 2008 - 2010.

In March 2007, requested AERS data showed at that time there were 15,571 reported adverse events to lupron/leuprolide, with 296 reported deaths, involving 3,189 individual safety reports.

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At left, the entire 'individual safety report' on male, female, and fetal deaths from previous years of leuprolide/Lupron AERS reports have been reproduced fyi. Data only pertains to selective Male death reports for the time period 11/1997 through 12/2004; Female death reports for 11/1997 through 8/2006; and Fetal deaths for 11/1997 through 12/2004 - a total of 180 deaths.

The FDA AERS FOIA Reports reproduced in links at left (presently as downloaded documents) have been provided in their entirety and contain all information as found in the FDA AERS FOIA Reports. A number of these AERS Reports lack critical information (i.e., age, "duration" of Lupron/leuprolide).

In the AERS Reports, the phrase "Preferred Term" is defined by the FDA as "The reported reaction, in medical terminology [as coded by MedDRA], describing the event." The phrase "Primary Suspect" is defined by the FDA as "The drug that the initial reporter deemed most likely to be associated with the reactions." A "Concomitant drug" is defined by the FDA as "A list of any drugs taken at the same time as the suspect medication, but not suspected of causing the adverse event."

Additional information beyond that listed in the AERS FOIA Reports can be obtained from the FDA by requesting individual ISR (Individual Safety Numbers) reports. These ISR numbers are provided within the AERS report.

Patients/consumers are 'advised' that "information in FDA Adverse Event reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions."

Tell me then, how does the incidence and significance of adverse lupron/leuprolide reactions become established? If people who become seriously ill or die after exposure to lupron do not raise an alarm and warrant substantive investigation ... what does? If the former 10,000+ National Lupron Victims Network did not cause 'concern' ... what will? If the current thousands of women complaining to their doctors and on the internet is not significant ... what would be significant? If all the settled lupron lawsuits are not indicative of 'a problem' - how many lawsuits will it take? How much of a critical mass in suffering and disability and death is required to warrant an investigation? Just how many deaths will it take?

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In a Cafepharma Message Board post ("2-14-11 at 3:23 pm"), an anonymous poster states: "The 6 Month dosage of Lupron will KILL patients. That's the real story here. Then finally the FDA will wake up and take Lupron off the market. ..."

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This website also provides selective reports of lupron/leuprolide deaths - reporting 145 deaths submitted to FDA AERS during the period October 2011 through September 2012 (mostly male deaths).

Another website had stated FDA AERS, for the period of November 1997 through August 2012 report 1,526 Deaths. (This link is defunct, as this website is now by subscription.)

A current search of OpenVigil, which contains AERS data, reveals only a fraction of the "deaths" that have already been reported to FDA's AERS database for Lupron/leuprolide - and the reason for this discrepancy is not clear. (data accessed on 4-27-14 reported "74 deaths" for leuprolide, and "204 deaths" for Lupron).

Another website providing data, "eHealthMe" (which claims reference by peer-reviewed journals) provides, imo, conflicting and confusing information. For example, on 4-27-14, eHealthMe states that there are 10,919 reports from FDA and social media of adverse events to Lupron. When queried, eHealthMe states it studied "4,487 people with side effects from "Lupron" and 308 have death", "308 people have Death of child", "308 people have Death of friend", "307 have Death of spouse", "307 have Death sudden", "307 have Death of sibling", and "308 have Death of friend" . ... For FDA and social media reports of adverse events to "leuprolide", eHealthMe states (on 4-27-14) that there are 3,900 reports, and they studied "2,142 people with side effects while taking leuprolide, and "124" or "128" had Death.

eHealthMe also shows (on 4-29-14) that Zoladex (goserelin) had "273" or "279" deaths. Trelstar had "8 deaths of child" - 100% of which had prostate cancer. Likewise, Eligard had "20 deaths".

Given that the above internet sources are not comprehensive, it would appear that the most accurate information on any AERS data, including for deaths, is through a FOIA request to FDA.

However, there are 3 caveats about FDA AERS data that must be born in mind:

#1: "In 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). A 2000 GAO report (page 6) noted that "FDA's [AERS] 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, for example, if taking the rate of a 1% reporting incidence - the 651 reported deaths by the FDA in 2009 signify a potential total of 65,100 deaths by 2009.

#2: NO DATA, including number of deaths, is ever provided for the time period of April 1985 through October 1997. This dozen years of data is stored separately and apart from the FDA AERS reports, and is NOT included in any FDA AERS tally of adverse events. FDA AERS database for Lupron/leuprolide begins at November 1997, and therefore does not contain ANY April 1985 through September 1997 Lupron/leuprolide adverse event reports.

#3: It appears that MedWatch reports submitted to FDA, reporting serious adverse events (i.e., the deaths of 2 young women), are not to be found listed within relevant time-frames in the FDA's AERS database. See details in Open Letter to FDA.

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The majority of women are prescribed lupron/leuprolide for benign and non life-threatening conditions (although some women are prescribed lupron/leuprolide for treatment of various cancers).

Treatment of benign conditions in women should not result in death, or serious illness.

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Send a MedWatch Report to FDA about Lupron/leuprolide Adverse Events, Deaths.