Posted by Article on 2/25/2002, 9:06 am

Wonder drug for men alleged to cause harm in women by Kay Lazar Sunday, August 22, 1999 First in a two-part series. Something strange happened to Susan Hayward while taking a drug called Lupron for a gynecological problem. She started losing her memory. That was in 1992, when Hayward was 36. Over the next five years, Hayward, a healthy, active postal worker, was given 18 more injections of the drug. Other curious health problems followed. She developed herniated discs, her body ached all over, and her memory worsened. Two years after she stopped taking the drug, Hayward, now 43 and living in Carver, is on disability and has trouble remembering basic things, like conversations she had earlier in the day. She suspects Lupron triggered irreversible changes in her brain. ``I went to college and I feel like I am an idiot now, because I can't remember anything,'' Hayward said. ``There has to be some connection.'' Hayward is hardly alone. Scores of women nationwide have reported to federal health officials serious side effects from Lupron, a drug originally developed to treat men with advanced prostate cancer but now widely used to treat women for a variety of routine gynecological problems. The serious side effects reported by women include tremors, seizures, memory loss and joint pain. The problem is, some women say these side effects are not going away - even after they stop taking the drug. Lupron's manufacturer insists its product is safe. The Food and Drug Administration, the federal agency that approves drugs for public use, says the benefits from Lupron outweigh the risks. But a growing number of women, women's health advocates and medical ethicists question that, saying the potent drug designed for men who have few other treatment options for advanced prostate cancer is being widely used on young, healthy women - without enough studies to show whether it causes long-term, and possibly irreversible, side effects. ``Lupron is something that sends a substantial number of women into a tailspin,'' said Judy Norsigian, program director for the Boston Women's Health Book Collective, a co-author of ``Our Bodies, Ourselves.'' ``It's one of the drugs that we feel has not been adequately assessed.'' Despite this worry, dozens of interviews of women and medical experts by the Sunday Herald indicate Lupron is commonly used by doctors, including specialists who prescribe it for treatment of infertility in women. The FDA has never OK'd Lupron for infertility treatments. And medical experts and women's advocates say not enough studies have been done to show whether Lupron is safe or effective for that use. Yet the FDA allows Lupron to be used for infertility treatments because under federal law, once a drug is approved for one use, doctors can prescribe it for any use. ``I have used Lupron (on infertility patients) for as long as it's been available,'' said Dr. Richard Reindollar, director of the division of Reproductive Endocrinology at Beth Israel Deaconess Medical Center. Reindollar also holds a similar position at Boston IVF, one of the region's highest-volume infertility clinics. ``While many patients do not like the side effects of Lupron, I do not remember one patient with such an extreme reaction requiring her to stop the medication,'' Reindollar said. Lupron, which is given by injection, was first approved by the FDA in 1985 solely for treatment of men with advanced prostate cancer. The drug is made by Deerfield, Ill.-based TAP Pharmaceuticals Inc., which is a joint venture of Abbott Laboratories and Takeda Chemical Industries, Japan's largest drug company. By 1989, a year before the FDA granted TAP permission to market the drug for limited use in women, TAP was aggressively promoting Lupron to obstetricians and gynecologists, FDA records show. The FDA warned TAP in a March 1990 letter that, ``Your firm has undertaken a deliberate campaign to promote this product for a wide range of unapproved uses.'' The letter warned the company to stop such promotions, especially the distribution of brochures targeted at consumers. ``They claim that Lupron is safe and effective, and actively promote its administration in a range of indications for which Lupron is not approved and apparently has not been adequately demonstrated to be safe and effective,'' the letter noted. After finishing its review of the drug, the FDA approved Lupron in October 1990 for limited use in women, for the treatment of endometriosis. In 1995, the FDA OK'd the drug for treatment of uterine fibroids. [Part One continued in next post]