"Pill Scare" Making a Comeback

New York, N.Y. (WFS) -- For years, the phrase "pill scare" evoked memories of days when high estrogen first-generation pills were wreaking havoc with women's health. But the phrase is making a comeback. Only this time around, scientists and health experts are trying to head off what they foresee as needless alarm on the part of oral contraceptive users. The "third generation" pills in question today contain the hormones desogestrel and gestodene. These have recently been the subject of three unpublished studies showing an increased risk of blood clots. In the U.S., pills containing desogestrel are sold under the brand names Desogen and Ortho-Cept. "At this time we've advised there's no need for anyone to change what they are taking. What could be most damaging now is a pill scare," says Susan Lamontagne, vice president for media affairs for Planned Parenthood. "You would have much worse effects resulting from unintended pregnancies and abortions." Scientists and health experts are fearful the unpublished studies will cause undue alarm in women who take these pills. Even the author of one of the studies has weighed in with a disclaimer. "The findings of our study are no cause for alarm among patients or doctors," says professor Walter O. Spitzer, epidemiologist from the McGill Faculty of Medicine, Montreal, Canada, and principal investigator of one study conducted throughout five European countries. However, women's health advocates argue that women taking birth control pills -- between eight to 10 million women in the U.S. -- are quite capable of evaluating the new information and making panic-free decisions. Currently, 15 percent of oral contraceptive users (or about 1 million women) in the U.S. take Desogen or Ortho-Cept. "Once experts know something and accept it as real, then women deserve to know," says Cindy Pearson, program director for the National Women's Health Network, an advocacy organization based in Washington, D.C. However small the risk, it's an avoidable one, says Barbara Seaman, health advocate and author of a ground-breaking 1969 book, The Doctor's Case Against the Pill. The FDA came forward recently after German drug regulators said the pills should no longer be prescribed to women under 30. The FDA responded by releasing a "talk paper" saying the agency had reviewed the three studies in question and found that "the risk is not great enough to justify switching to other products." "The whole range of risks here are much lower than those of the old high-dose pill," said Dr. Bruce Stadel, a medical officer and epidemiologist for the Division of Metabolism and Endocrine Drug Products with the FDA. Epidemiological studies conducted by the World Health Organization show the effects of oral contraceptives vary widely among women, but in each scenario a blood clotting condition known as deep venous thrombosis can occur. DVT is a condition in which blood clots form in the veins, usually in the legs. Warning signs include leg pains, usually in the calf. If 100,000 healthy women not taking oral contraceptives were observed for one year, only five of them would be expected to develop blood clots in the leg. By contrast, if a group of 100,000 healthy women, ages 15 to 34 taking low-estrogen birth control pills were observed for one year, 10 to 15 of this group would likely suffer from blood clots. However, the studies show that for women taking pills containing both desogestrel and gestodene, the numbers double, with 20 to 30 women expected to develop blood clots in the leg, Stadel said. This is not high, said Stadel, especially when you consider that the number would double again to 60 if the group were healthy pregnant women who gave birth in that 12-month period. "That's just to put it in perspective," said Stadel. Pearson, reacting to the numbers, drew this conclusion: "It's not an emergency," she said. "But women should not lightly continue with desogestrel or gestodene without having a conversation with their physician." While the numbers might not be overwhelming, Seaman says they still must be taken seriously by women. "Blood clots are serious and can be life threatening. So to the individual user, it's always a big deal." Deep venous thrombosis is a treatable condition, but potentially serious. In some cases, it can become a potentially fatal condition, known as venous thromboembolism, which occurs when a blood clot migrates. Predisposing factors to DVT include the presence of varicose veins, a history of vascular disease, obesity, surgery or prolonged immobility. Blood clots from DVT are "not life threatening in and of themselves," said Dr. Adriane Fugh-Berman, a medical officer in the Contraceptive Development Branch of the U.S. National Institute of Child Health and Human Development. "However, if a blood clot travels to the heart, lung or brain it can be life threatening. In all cases, DVT requires immediate treatment," said Fugh-Berman. Further complicating the picture is the fact that the so-called "third generation" pills in question may have positive benefits in reducing heart attacks, something older pill users are more at risk for. Regulators in Europe -- where more women use the pills in question -- have decided to take action against the pills even before all the studies are published and reviewed. In Germany, the Federal Institute for Drugs and Medical Devices said that the pills containing desogestrel and gestodene shouldn't be prescribed to women under 30 who are taking the pill for the first time. Shering AG, the world's largest maker of the pills, said it would appeal the decision. The Committee on Safety of Medicines in Britain, where half of all pill users take oral contraceptives containing desogestrel or gestodene, has recommended that women with risk factors such as varicose veins and obesity shouldn't use pills containing the substances. The timing of these actions have prompted criticism from health officials and scientists, said Fugh-Berman. "That's a reasonable decision," she says. "But it's also a reasonable decision to wait until a study has been published and reviewed before publicizing the findings." Planned Parenthood, which reviews its own records, will continue to keep users informed, said Lamontagne. "There are ample warnings that go along with all oral contraceptives which need to be taken in conjunction with monitoring by a physician," she says.

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