Posted by Article on 2/25/2002, 9:08 am

[Part One Continued] To date, the FDA reports 6,272 complaints filed for adverse side effects from Lupron - 553 have come within the past 20 months. During the past two years roughly 2 million prescriptions were written for Lupron in the United States, according to IMS Health, a Pennsylvania company that tracks prescription drugs. The FDA's records also include 25 women's deaths where Lupron was listed among the suspected, but not proven, causes. The number of suspected problems could be even larger, because the FDA itself says such ``adverse events'' are generally underreported. The agency notes that 90 percent of adverse reports come from drug manufacturers, who are required by law to report adverse effects. Doctors are not required to report bad side effects to the FDA, but may report them on a voluntary basis, to the FDA or the drug manufacturer. The FDA also says that it has not ``scientifically or otherwise verified'' any link between Lupron and the reported adverse effects. However, at least one document indicates there is concern within the FDA about the growing reports of adverse effects from Lupron. In a March 24, 1999 memo, obtained by the Sunday Herald under the Freedom of Information Act, an FDA epidemiologist who reviewed Lupron reports concluded there were ``high prevalence rates'' for serious side effects. She suggested her agency consider a ``re-examination of the product label to ensure that these events are adequately addressed.'' In an interview, Dr. Marianne Mann, the FDA's deputy director for the Division of Reproductive and Urologic Drug Products, said her department did review its data after that report and decided no additional action was needed. ``Our clinicians reviewed this data and reviewed the Lupron (package warnings) and we feel the current Lupron (warnings) adequately reflects these concerns,'' Mann said. Like many drugs, Lupron comes with inserts warning of a number of potentially serious side effects, including: depression, joint disorders plus loss of bone density, or osteoporosis. Yet none of the warnings - except for bone loss - state the side effects might continue long after stopping use of the drug. However, seven of the women interviewed for this story say they suffered memory loss and bone aches while on Lupron, and that the problems continue years after stopping the drug. Some say seizures and serious vision problems that started while on Lupron also haven't gone away. One woman, Linda Abend in southern New Jersey, started a National Lupron Victims Network after her 34-year-old sister was hospitalized with seizures while taking Lupron in 1991 for a benign fibroid. Abend says her sister continues to suffer daily seizures, plus debilitating bone and muscle pain eight years later. And Abend said she has heard from more than 1,000 people nationwide - mostly women - who also report serious side effects that continue after stopping Lupron. The FDA says it has not tracked claims of such long-term effects. ``Our post-marketing system works on getting information from these adverse events,'' Mann said. ``We accumulate data over time, and it takes a while to get this data. At present we feel the label adequately addresses these issues.'' But University of Pennsylvania bioethicist Glenn McGee, who specializes in reproductive issues, says the FDA is making a mistake. ``We just don't know yet what Lupron causes,'' McGee said, ``but there is enough evidence that something is wrong and that the FDA should initiate studies.'' Despite the mysterious health problems some link to Lupron, others swear by the drug. Manny Hamelburg, of Braintree, says Lupron saved his life. Hamelburg, 59, started taking Lupron in 1992, when he was diagnosed with advanced prostate cancer and given a bleak prognosis. Hamelburg said he believes his cancer is in remission because of Lupron. But, he said, he stopped taking Lupron this May because he was diagnosed with osteoporosis, which he believes was caused by Lupron. ``Lupron was a wonder drug, but it was costly,'' Hamelburg said. ``I have hot flashes, loss of libido, I've gained weight, I'm over 300 pounds, my breasts are enlarged. I can live with these. They are a pain in the neck, but they are livable.'' In a statement, TAP Pharmaceuticals said it has ``compassion'' for the long-term side effects a growing number of women have complained about. The company also said its product is safe and has helped many patients. ``Since Lupron's approval, which was nearly 10 years ago, hundreds of thousands of endometriosis and uterine fibroid sufferers have used Lupron safely, and Lupron has not been found to have any irreversible or lasting side effects,'' said TAP's Kim Modory. Yet the case of Victoria Lee Burns in Maryland raises questions about that claim. In 1991, Burns, who was in her 20s and working in a bank, took five monthly injections of Lupron for endometriosis and ended up hospitalized for severe arthritis-like symptoms, according to her lawyer, Nicole Schultheis. ``Contrary to what was stated in the literature, her symptoms were not reversible upon cessation of therapy,'' Schultheis said, adding that her client remains permanently disabled from Lupron, and struggles daily with walking, driving and standing. Burns sued TAP Pharmaceuticals in 1994. ``They refused to produce documents until I agreed I would keep them secret and I refused to do that,'' Schultheis said. In January 1997, TAP settled the case. The terms of the settlement are secret. TOMORROW: Women who have taken Lupron, and their campaign to get an investigation of the drug. Reporting drug woes To report a suspected adverse side effect from a drug or medical device, call the federal Food and Drug Administration at (888) INFO-FDA. Consumers can also file reports on line at www.fda.gov (click on MedWatch Medical Products Reporting). ``The patient's identity is held in strict confidence by the FDA and protected to the fullest extent of the law,'' the federal agency says. Contact TAP Pharmaceuticals Medical Services Department at (800)622-2011, or www.lupron.com. Call the National Lupron Victims Network at (609) 858-2131. The Internet address is www.voicenet.com/~nlvn. For information about a Lupron petition to the FDA, visit www.delphi.com/afterlupron.