Pfizer, the world’s largest drug maker, is seeking approval for Fablyn, a drug to treat postmenopausal women with osteoporosis. Osteoporosis is a serious condition that can cause bone thinning and fractures. Company studies of Fablyn show that the drug effectively treats osteoporosis and has positive results for preventing fractures. However, the FDA’s review of the data also led to concerns about deaths and blood clots in women who used Fablyn. Other problems seen in the studies include stroke and an increased rate of gynecological issues such as vaginal bleeding and abnormal uterine growths. In the studies, deaths from cancer and stroke were more likely in women taking Fablyn than women taking a placebo. At issue now for the FDA is whether the benefits of the drug outweigh the safety concerns. A panel of advisors to the FDA will review the data and make recommendations to the agency. The FDA usually follows the panel’s advice, but is not required to do so.
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