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DEATHS

Updated FAERS (FDA Adverse Event Reporting System) data on DEATHS from "Lupron Depot-PED", "Lupron Depot" (all dosages), and "Lupron" (leuprolide - daily injection) for May 2011 through May 2016 are found at right column -

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Between 2004 and 2012, "Death" was ranked as #11 in the 'Top 20 Adverse Events Associated With Lupron'.

Now (between 2004 through 2015), "Death" is ranked as #8 in the 'Top 20 Adverse Events Associated With Lupron'.

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PEDIATRIC DEATHS:

According to FDA AERS data obtained under the Freedom of Information Act -

For the five year period May 2011 through May 2016, there were 39 "total [pediatric] deaths", and there were also 10 "events" listing a pediatric death.

In a Phase 3 & 4 clinical trial to study the safety and efficacy of Lupron Depot in treatment for Central Precocious Puberty, one child died from respiratory infection and heart arrest, but (in typical Lupron clinical trials' fashion) the adverse event was "considered not related to study drug by investigator". (Of 7 other serious adverse events that emerged during this trial, 5 of the 7 serious adverse events were "considered not related to study drug by the investigator".)

In a study of selected reports for October 2011 through September 2012 (one year), 2 pediatric female deaths were reported to FDA as possible side effects to Lupron Depot-PED (see reports dated 5-10-12 and 8-23-12).

In the 'RxISK.org' search engine for FDA AERS for 2004-2014, 3 deaths are reported for Lupron Depot-PED for the age range of '1-13 years old' (and an additional death is reported for age range '13-20').

2002 (June 17): Death of 12 Year Old Boy From Intraventricular Hemorrhage After Lupron Depot-Ped

2000 (August 25): Death of 16 Year Old Female From Suicide After Lupron Depot

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Deaths (and Harm) From Hyperstimulation of Ovaries (in which the woman receives a drug/chemical coctail consisting of numerous drugs, including Lupron or other GnRHa's/relins, or GnRH antagonists, prescribed to maximize egg production)

Brittany Maynard recently made news as she moved to Oregon and took her own life because of terminal brain cancer. "Advocates for aid-in-dying laws say Maynard’s story has recharged legislative efforts across the nation". But no one across this nation (with the exception of Jennifer Lahl) is publicly discussing the fact that Brittany Maynard was a repeat egg donor. What are 'The Connections' between Maynard, egg donations, Lupron & gliobastomas ? (by Jennifer Lahl)

Fatal Colon Cancer in a Young Egg Donor (leuprolide used in hyperstimulation)

"Undetermined Cause of Death" in a healthy 27 year old woman, 21 days following one injection of lupron: See mother's "August 5, 2011" post here

Sudden death due to "flare" in prostate cancer treatment

"Use of Lupron/leuprolide During Pregnancy Has Resulted in Fetal and Newborn Death"

02-05-11: Data samples: eHealthMe study of leuprolide/Eligard deaths

04-14-12: Data samples: eHealthMe study of Lupron Sudden Death

Selected DrugLib.com lupron/leuprolide deaths

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Review of FDA AERS Reports 1997 - 2004/2006

Found below are reproductions of FDA AERS FOIA Reports of Deaths in Females , Fetuses, and Males after the use of Lupron/leuprolide.

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FEMALE DEATHS 1997 through 2006:

Note: the below represents a chronological review of FDA AERS FOI Reports for Female Deaths for the period of November 1997 through August 2006 only.

Death of Female From Thrombocytopenia - Lupron "Primary Suspect" (01-14-98)

Death of 45 Year Old Woman, 6 Days After 1 Dose of Lupron (04-07-98)

Death of 40 Year Old Woman From Respiratory Distress After Lupron (09-08-98)

Death of 45 Year Old Woman From Malignant Disease After Lupron 3.75 mg (12-09-98)

Death Of 39 Year Old Woman Following Lupron Depot 3.75 mg (10-21-99)

Death of 46 Year Old Female From Suicide After Lupron (03-01-00)

Death of 35 Year Old Female After Lupron Depot 3.75 mg (05-02-00)

Death of 22 Year Old Female From Intracranial Aneurysm After One Injection of Lupron Depot (05-11-00)

Death of 47 Year Old Female From Endoemtrial & Uterine Cancer After Lupron Depot (05-19-00)

Death of 41 Year Old Female From Sudden Death, Mitral Valve Prolapse After One Injection of Lupron Depot (06-21-00)

Death of 16 Year Old Female From Suicide After Lupron Depot (08-25-00)

Death of 51 Year Old Female From Anaphylactic Reaction After One Dose of Lupron Depot (10-16-00)

Death of 51 Year Old Female From Multi-Organ Failure, Analphylactic Reaction After One Dose of Lupron Depot (10-17-00)

Death of 40 Year Old Female From Cerebral Infarction After Lupron 1.88 mg (09-12-01)

Death of 40 Year Old Female After One Dose of Lupron Depot-3 Month 11.25 Mg (11-30-01)

Death of 50 Year Old Female After 6 Months of Lupron 3.75 mg (04-03-02)

Death of 47 Year Old Female From Cardiac Arrest After One Injection of Lupron 3.75 mg. (09-19-02)

Death of 18 Year Old Female From Suicide After One Injection of Lupron Depot-3, 11.25 mg (01-13-03)

Death of 43 Year Old Female From Cancer Metastases to Liver After Lupron 3.75 mg. (03-07-03)

Death of Female After Lupron Depot 3.75 mg (04-17-03)

Death of 31 Year Old Female After One Dose of Lupron 3.75 mg (05-08-03)

Death of 1 Day Old Infant From Multiple Congenital Abnormalities After Lupron Depot 3.75 mg. (05-13-03)

Death of 51 Year Old Female From Cerebral Haemorrhage After Lupron 1.88 mg. (05-27-03)

Death of 27 Year Old Female From Carbon Monoxide Poisoning After Lupron 3.75 mg (07-21-03)

Death of 49 Year Old Female After 5 Months of Lupron 1.88 mg (05-03-05)

Death of 44 Year Old Female From Carotid Artery Aneurysm After Lupron Depot 3.75 mg (05-04-05)

Death of 37 Year Old Female From Carotid Artery Occlusion/Thrombosis, Cerebral Infarction After Leuplin (leuprolide) 1.88 mg (12-02-05)

Death of 42 Year Old Female From Acute Myocardial Infarction After 2 Months of Leuplin (lupron) 3.75 mg (01-19-06)

Death of 42 Year Old Female From Brain Death, Intracranial Aneurysm After Lupron 3.75 mg (03-07-06)

Death of Newborn Male Infant From Multi-Organ Failure, Congenital Heart Disease, Skull Malformation, Trisomy 13 After Transplacental Exposure to Lupron Depot 3.75 mg (08-31-06)

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FETAL DEATHS 1997 through 2004:

Note: the below represents a chronological review of FDA AERS FOI Reports for All Fetal Deaths for the period of November 1997 through December 2004 only.

Fetal Death From Induced Abortion Due to Hydrocephalus After Daily Lupron 0.1 MG (04-17-98)

Fetal Death From Induced Abortion Due To Trisomy 21 After Lupron Depot (09-10-98)

Fetal Death From Induced Abortion Due to Trisomy 18 After Daily Lupron 0.2 ml (03-04-99)

Fetal Death From Abortion After Lupron 3.75 mg (01-03-00)

Fetal Death From Abortion After Lupron 3.75 mg (06-01-01)

Fetal Death From Induced Abortion Due To Chromosome Abnormality After Lupron (02-15-02)

Fetal Death From Spontaneous Abortion After Lupron Depot 3.75 mg (04-10-02)

Fetal Death From Induced Abortion Due To Complications Of Maternal Exposure To Lupron 1.5 mg (12-10-03)

Fetal Death From Spontaneous Abortion After Lupron Depot 3.75 mg (12-23-03)

Fetal Death From Spontaneous Abortion After Lupron Depot 3.75 mg (12-23-03)

Multiple Fetal Deaths From Intra-Uterine Death After Lupron (02-13-04)

Fetal Death From Spontaneous Abortion Due To Fetal Growth Retardation, Fetal Cardiac Disorder After Lupron 0.5 mg (06-10-04)

Fetal Death From Spontaneous Abortion After Lupron 3.75 mg (10-12-04)

Fetal Death From Spontaneous Abortion After Lupron Depot-3 11.25 mg (08-15-06)

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MALE DEATHS 1997 through 2004:

Note: the below represent a chronological review of AERS FOI Reports of Male Deaths for the time period of November 1997 through December 2004 only.

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Death of 65 Year Old Male, 2 Days After Lupron (12-04-97)

Death of 70 Year Old Male From Cardiac Arrest, Circulatory Collapse After Lupron 7.5 mg (12-05-97)

Death of Male From Disseminated Intravascular Coagulation, Sepsis After Injection of Leuprorelin 3.75 mg (12-10-97)

Death of 86 Year Old Male From Cardiac Failure, Gastrointestinal Hemorrhage After 6 Months of Lupron 3.75 mg (01-29-98)

Death From Disseminated Intravascular Coagulation (02-18-98)

Death of 75 Year Old Male From Disseminated Intravascular Coagulation, Respiratory Arrest After One Day of Lupron 3.75 mg(03-10-98)

Death of 83 Year Old Male From Fall, Hip Fracture After 9 Months of Lupron 22.5 mg (03-12-98)

Death of 81 Year Old Male From Fall, Hip Fracture After Lupron 7.5 mg (03-12-98)

Death of 77 Year Old Male From Syncope, Fall, Hemorrhagic Stroke After One Dose of Lupron 7.5 mg (04-06-98)

Death of 57 Year Old Male From Myocardial Infarction After Procrin (Lupron) 22.5 MG (04-27-98)

Death of 74 Year Old Male From Myocardial Infarction After First Dose of Lupron 3.75 mg (04-28-98)

Death of 70 Year Old Male From Cardiac Arrest, Circulatory Collapse After Lupron 7.5 mg (05-11-98)

Death of 70 Year Old Male From Disseminated Intravascular Coagulation, Sepsis, Enterocolitis After Lupron 3.75 mg (06-08-98)

Death of 77 Year Old Male From Hepatic Encephalopathy 2 Days After Lupron 3.75 mg (06-29-98)

Death of 83 Year Old male From Hemorrhagic Stroke 10 Months After Lupron 11.25 mg (07-01-98)

Death of 88 Year Old Male From Shock After 6 Months of Lupron 11.25 mg (07-17-98)

Death of 68 Year Old Male From Cardiac Failure After 5 Months of Lupron 11.25 mg (08-17-98)

Death of 73 year Old male From Diabetic Coma After Lupron Depot-3 (10-29-98)

Death of 80 Year Old Male From Cardiac Failure, Shock After Lupron 11.25 mg (11-19-98)

Death of 76 Year Old Male From Cardiac Failure, Myocardial Infarction After Lupron 7.5 mg (11-25-98)

Death of 71 Year Old Male From Hepatitis Fulminant After 1 Day of Lupron 3.75 mg (12-01-98)

Death of 75 Year Old Male From Respiratory Arrest After 19 Days of Lupron 3.75 mg (12-30-98)

Death of Male From Cardiac Failure After 1 Month of Lupron 11.25 mg (01-13-99)

Death of 73 Year Old Male From Pneumonia After 11 Months of Lupron 11.25 mg (01-29-99)

Death of 81 Year Old Male After 1 Month of Lupron 11.25 mg (02-17-99)

Death of 85 Year Old Male After 6 Months of Lupron 3.75 mg (03-04-99)

Death of 69 Year Old Male From Lung Cancer After 113 Days of Lupron 3.75 mg (03-04-99)

Death of 71 Year Old Male From Cardiac Failure, Shock After Lupron 3.75 mg (03-04-99)

Death of 70 Year Old Male From Gastric Cancer After 4 Months of Lupron 3.75 mg (03-04-99)

Death of 51 Year Old Male From Lung & Prostate Cancer After 8 Months of Lupron 11.25 mg (04-19-99)

Death of 78 Year Old Male From Myocardial Infarction After 1 Year of Lupron 11.25 mg (05-03-99)

Death of Male From Interstitial Lung Disease After 68 Days of Lupron 3.75 mg (05-26-99)

Death of 66 Year Old Male From Myocardial Infarction After 6 Weeks Of Lupron (05-28-99)

Death of 82 Year Old Male From Cardiac Arrest, Respiratory Failure, Disseminated Intravascular Coagulation After 2 Days of Lupron 3.75 mg (06-03-99)

Death of 67 Year Old Male From Prostate Cancer After Lupron 11.25 mg (06-18-99)

Death of 78 Year Old Male After Lupron Depot-4 30 mg (07-16-99)

Death of 82 Year Old Male From Anemia, Vomiting After Lupron Depot-4 30 mg (07-16-99)

Death of 74 Year Old Male From Cerebral Infarct, Convulstion After 44 Days of Lupron 3.75 mg (09-01-99)

Death of 76 Year Old Male After Lupron 11.25 mg (09-03-99)

Death of 74 Year Old Male After Lupron 11.25 mg (09-03-99)

Death of 63 Year Old Male From Cardiac Failure 2 Months After Lupron (09-10-99)

Death of 69 Year Old Male From Cerebral Infarction 49 Days After Lupron (09-13-99)

Death of 66 Year Old Male From Malignant Neoplasm After 184 Days of Lupron 11.25 mg (09-20-99)

Death of 67 Year Old Male From Cardiac Disorder After Lupron 7.5 mg (10-12-99)

Death of 80 Year Old Male From Acute Respiratory Distress After Lupron 22.5 mg (10-13-99)

Death of 79 Year Old Male From Cardiac Arrest After 36 Days of Lupron 3.75 mg (10-13-99)

Death of 76 Year Old Male From Arrhythmia, Myocardial Infarction After Lupron 30 mg (01-20-00)

Death of 85 Year Old Male From Cardiac Failure, Respiratory Distress AFter 49 Days of Lupron 3.75 mg (03-13-00)

Death of 85 Year Old Male From Cardio-Respiratory Arrest After 171 Days of Lupron 3.75 mg (05-02-00)

Death of 85 Year Old Male From Stevens-Johnson Syndrome, Renal Impairment After Lupron Depot-4 30 mg (05-03-00)

Death of 74 Year Old Male From Pulmonary Embolism After Lupron Depot (06-23-00)

Death of Male From Cardiac Failure, Heart Transplant After Lupron 7.5 mg (07-19-00)

Death of 74 Year Old Male From Pulmonary Embolism After 32 Days of Lupron Depot (07-24-00)

Death of Male From Malignant Neoplasm After Lupron Depot-4 30 mg (07-24-00)

Death of 74 Year Old Male From Amyotrophic Lateral Sclerosis After Lupron 3.75 mg & 11.25 mg (08-02-00)

Death of 79 Year Old Male From Cerebrovascular Accident After Lupron 7.5 mg (08-04-00)

Death of 81 Year Old Male From Hemolytic Anemia, Pulmonary Infarction, Renal Failure After 8 Months of Lupron 3.75 mg (09-06-00)

Death of 78 Year Old Male From Disseminated Intravascular Coagulation, Cardiac Failure After 5 Months of Lupron 3.75 mg (09-28-00)

Death of 86 Year Old Male From Pneumonia After Lupron Depot (10-05-00)

Death of 86 Year Old Male After 1 Day of Lupron 3.75 mg (11-03-00)

Death of 81 Year Old Male From Hemolytic Anemia, Cardiac Arrest, Renal Failure After 225 Days of Lupron 3.75 mg (11-06-00)

Death of 82 Year Old Male From Disseminated Intravascular Coagulation, Respiratory Failure After Lupron 3.75 mg (11-28-00)

Death of Male From Respiratory Failure After 3 Years of Lupron Depot (12-12-00)

Death of Male From Lung Disorder After 2 Years of Lupron Depot (12-12-00)

Death of 66 Year Old Male From Cardiac Failure After Lupron 22.5 mg (03-13-01)

Death of 81 Year Old Male From Pneumonia After 1 Day of Lupron 3.75 mg (03-22-01)

Death of 82 Year Old Male After Lupron 11.25 mg (05-16-01)

Death of 68 Year Old Male From Myocardial Infarction After 1 Injection of Lupron (06-19-01)

Death of 83 Year Old Male From Thrombocytopenia, Sepsis After Lupron 3.75 mg (07-09-01)

Death of 79 Year Old Male From Malignant Neoplasm After 6 Months of Lupron Depot-3 11.25 mg (07-17-01)

Death of 74 Year Old Male From Dyspnea, Pneumonia After "Days" of Lupron Depot-3 11.25 mg (08-03-01)

Death of 92 Year Old Male From Pneumonia After 1 Dose of Lupron 3.75 mg (08-08-01)

Death of 29 Year Old Male From Suicide After 156 Days of Lupron Depot-3 (08-08-01)

Death of 71 Year Old Male From Myocardial Infarction After Trenantone (leuprolide) 11.25 mg (10-08-01)

Death of 81 Year Old Male From Renal Failure After 1 Day of Enantone (Lupron) 3.75 mg (03-07-02)

Death of Male From Cardiac, Respiratory Failure After Lupron 3.75 mg (05-01-02)

Death of Male From Lung Disorder After Lupron Depot-3 (05-17-02)

Death of 79 Year Old Male From Cardiac, Respiratory Arrest, Disseminated Intravascular Coagulation After 225 Days of Lupron 3.75 mg (06-06-02)

Death of 12 Year Old Boy From Intraventricular Hemorrhage After Lupron Depot-Ped (06-17-02)

Death of 72 Year Old Male From Prostate CA Progression, Renal Failure After Viadur (Leuprolide Implant) 120 mcg (08-23-02)

Death of 77 Year Old Male From Disease Progression, Pneumonia After Viadur (Leuprolide Implant) 120 mcg (08-23-02)

Death of 78 Year Old Male From Delirium, Hemiplegia After 31 Days of Lupron 3.75 mg (09-06-02)

Death of 73 Year Old Male From Cardio-Respiratory Arrest, Renal Failure After 1 Day of Lupron Depot 11.25 mg (11-05-02)

Death of 76 Year Old Male From Injection Site Edema After Eligard (leuprolide) (12-24-02)

Death of 80 Year Old Male After Enantone (leuprolide) (01-14-03)

Death of 67 Year Old Male From Traffic Accident After 94 Days Of Trenantone (leuprolide) 11.25 mg & 179 Days of Enetone Monatsdepot (leuprolide) 3.75 mg (01-23-03)

Death of 67 Year Old Male From Traffic Accident After 94 Days of Trenantone (leuprolide) 11.25 mg (01-27-03)

Death of 68 Year Old Male From Respiratory Arrest After Lupron 3.75 mg (02-12-03)

Death of 71 Year Old Male From Cerebral Hemorrhage, Metastases After 673 Days of Lupron 3.75 mg (02-20-03)

Death of 68 Year Old Male From Myelodysplastic Syndrome, Sepsis After Lupron Depot-3 (03-11-03)

Death of 71 Year Old Male From Myocardial Infarction After Eligard (leuprolide) 22.5 mg (05-21-03)

Death of 80 Year Old Male From Circulatory Collapse, Myocardial Infarction After Lupron 11.25 mg (05-21-03)

Death of 72 Year Old Male From Myocardial Infarction After Eligard (leuprolide) 22.5 mg (06-04-03)

Death of 87 Year Old Male From Suicide After 91 Days of Lupron 11.25 mg (06-23-03)

Death of 82 Year Old Male From Myocardial Infarction, Sudden Death After 1 Day of Lupron 11.25 mg (07-02-03)

Death of 72 Year Old Male From Cardiac Failure In Lupron 3.75 mg Study (07-08-03)

Death of 58 Year Old Male From Sudden Death After Leuprolide 3.75 mg (07-24-03)

Death of 83 Year Old Male From Myocardial Infarction After 3 Months of Trenantone (Lupron) 11.25 mg (07-28-03)

Death of 82 Year Old Male From Coma, Respiratory Failure After Viadur (leuprolide) Implant 120 ug (08-12-03)

Death of 81 Year Old Male From Multiple Myeloma, Metastases, Hepatitis After 2 Doses of Lupron Depot 11.25 mg (09-16-03)

Death of 83 Year Old Male From Coma, Respiratory Failure After Viadur (leuprorelin) 120 ug (09-22-03)

Death of 77 Year Old Male From Metastatic Prostate Cancer, Pneumonia After Trenantone (leuprolide) 11.25 mg (09-29-03)

Death of 85 Year Old Male After Trenantone (leuprolide) 11.25 mg (10/17/03)

Death of 87 Year Old Male From Cardiac Failure After Lupron Depot 7.5 mg (10-24-03)

Death of 90 Year Old Male From Disseminated Intravascular Coagulation, Hepatic Failure After 3 Injections of Lupron 3.75 mg (10-24-03)

Death of 64 Year Old Male From Lung Neoplasm After Lupron 11.25 mg (11-07-03)

Death of 66 Year Old Male From Thrombosis, Pulmonary Emboism After 104 Days of Trenantone (leuprolide) 11.25 mg (11-12-03)

Death of 81 Year Old Male From Cardiac Failure, Neoplasm Progression After 181 Days of Trenantone (leuprolide) 11.25 mg (11-20-03)

Death of 64 Year Old Male From Multiple Causes After Lupron 3.75 mg (12-31-03)

Death of 88 Year Old Male From Pancreatic Cancer After 8 Months of Lupron 3.75 mg and One Dose of Lupron 11.25 mg (03-03-04)

Death of Male From Hepatic Failure After Enanton Depot (leuprolide) 11.25 mg (03-22-04)

Death of 70 Year Old Male After Lupron Depot 7.5 mg (03-25-04)

Death of 89 Year Old Male From Interstitial Lung Disease After Leuplin (leuprolide) 11.25 & 3.75 mg (04-06-04)

Death of 80 Year Old Male From Malignant Neoplasm After Viadur (leuprolide) Implant 120 ug (05-04-04)

Death of 82 Year Old Male From Interstitial Lung Disease After Leuprlin 3.75 mg (05-05-04)

Death of 83 Year Old Male From Coma, Interstitial Lung Disease After 37 Months of Leuplin 3.75 mg (05-05-04)

Death of 77 Year Old Male From Cerebrovascular Disorder, Malignant Neoplasm After 463 Days of Lupron 3.75 mg (05-11-04)

Death of 83 Year Old Male From Bronchopneumonia, Myocardial Infarction After 533 Days of Leuprorelin 3.75 mg (05-11-04)

Death of 77 Year Old Male From Hepatic Failure After Enanton Depot (leuprolide) 11.25 mg (05-14-04)

Death of 71 Year Old Male After Lupron 22.5 mg (05-26-04)

Death of 89 Year Old Male From Acute Respiratory Failure After Leuplin 11.25 mg (06-04-04)

Death of 67 Year Old Male From Sudden Death, Circulatory Collapse, Myocardial Infarction After Lupron 11.25 mg (06-08-04)

Death of 67 Year Old Male From Cerebral Infarction, Respiratory Failure After Lupron Depot (06-15-04)

Death of 77 Year Old Male From Cardiac & Respiratory Failure After Lupron Depot 11.25 mg (06-25-04)

Death of 77 Year Old Male From Cardiac Arrest After Lupron 7.5 mg (07-06-04)

Death of 87 Year Old Male From Cardiac Failure After 4 Months of Trenantone 11.25 mg (07-23-04)

Death of 66 Year Old Male From Myocardial Infarction After Trenantone (Lupron) 11.25 mg (07-23-04)

Death of 77 Year Old Male From Acute Respiratory Distress After 1 Dose of Lupron Depot-4 30 mg (07-23-04)

Death of 76 Year Old Male From Cardiac Disorders, Disseminated Intravascular Coagulation After One Day of Eligard (Leuprorelin) 7.5 mg (07-26-04)

Death of Male From Myocardial Infarction After Trenantone (Leuprorelin) 11.25 mg (07-27-04)

Death of 83 Year Old Male From Intestinal Infarction After Trenantone 11.25 mg (07-27-04)

Death of 81 Year Old Male From Cardiac Failure, Metastases After Trenantone 11.25 mg (07-28-04)

Death of 67 Year Old Male After Trenantone 11.25 mg (07-29-04)

Death of 66 Year Old Male From Myocardial Infarction After Trenantone (Leuprorelin) 11.25 mg (08-06-04)

Death of 76 Year Old Male In Luprolide 22.5 mg Study (11-08-04)

Death of 82 Year Old Male From Multi-Organ Failure After 93 Days of Lupron 11.25 mg (11-17-04)

Death of 76 Year Old Male From Hepatic, Respiratory Failure After Eligard (Leuprorelin) 22.5 mg (12-07-04)

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

 

 

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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UPDATED DATA:

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.

 

 

 

 


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