This page will be devoted to addressing the Deaths of Males, Females, and Fetuses following the use of lupron/leuprolide.

The FDA maintains an Adverse Event Reporting System (AERS) for all drugs - reports that are submitted voluntarily by health professionals and consumers following an adverse event to a drug.

In March 2007, I requested AERS data on lupron/leuprolide, under the Freedom of Information (FOI) Act, and at that time the FDA reported there were 15,571 reported adverse events to lupron/leuprolide, with 296 reported deaths from lupron/leuprolide, involving 3,189 individual safety reports.

It should be remembered at all times that the incidence of reporting adverse events to the FDA, according to studies, has been found to represent a mere 1% to 10% of the number of actual adverse events experienced. Therefore, if taking the rate of a 1% reporting incidence, the 296 reported deaths signify a potential total of 29,600 deaths.

It should also be remembered that by the turn of the century, the National Lupron Victims Network had accumulated surveys from 10,000+ lupron victims ... clearly in excess of the FDA's 2007 number of "3,189 individual safety reports" from lupron/leuprolide. It is blatently obvious that the number of actual lupron adverse events are not being accurately reported to or reflected in the FDA AERS reporting system.

At present, I only have the FDA's adverse event reports for the period of November 1997 through December 2006, and do not yet have AERS for the period of 1984 through October 1997, nor from January 2007 to present. Because of my repeated illness and hospitalizations, a complete review of this data (and an updated report) remain pending.

The FDA AERS FOI Reports reproduced at left fyi, have been provided in their entirety and contain all information as found in the FDA AERS FOI Reports. A number of these AERS FOI Reports lack critical information, such as "duration" of lupron/leuprolide. In the AERS FOI 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."

It would appear that most reports of deaths after the use of lupron/leuprolide for the time frame November 1997 through December 2006 are for older men undergoing palliative treatment of prostate cancer. I will post some, but not all, of these older male prostate cancer deaths at left, and for a website where you can find more examples of male deaths, see 'Patientsville' link (below).

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 cancer). Treatment of benign conditions in women should not result in death (or serious illness). As I review the 1997 through 2006 FDA AERS FOI Reports and locate female and fetal deaths, all of these will be posted at left.

The FDA does not make its AERS FOI Reports available online, but these reports are available from the FDA for a fee, when requested under the Freedom of Information Act. AERS reports are provided on CD-ROM or in paper copy. Additional information beyond that listed in the AERS FOI Reports can be obtained from the FDA by requesting individual ISR (Individual Safety Numbers) reports.

There is also a non-governmental website that has posted a partial selection of lupron/leuprolide adverse events and deaths (2007 - 2008) online: http://www.patientsville.com/medication/lupron1_side_effects.htm.

The FDA, TAP, Abbott, the medical community, and doctors 'advise' 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, FDA, 'TAP', Abbott, the medical community and doctors - if there is no scientific or other type of verification to explore the cause and effect relationship ... 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 on the internet is not significant ... what would be? 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 is required to warrant an investigation? How many deaths will it take?

This page is under construction.