FDA Plans Rules on Drugs in Pregnancy
In response to the "lack of information" about prescription drug use during pregnancy, the FDA is developing new rules to help pregnant women use "some medicines more safely," the AP/Contra Costa Times reports. Under the FDA's plan, the agency would require drug labels to be updated annually with any "pregnancy safety data," such as independent research or patient case reports. West Virginia University clinical pharmacologist Tim Tracy, who leads "one of the few studies" on the subject, said 60% of women take "at least one" prescription medication during pregnancy, often prescribed by a physician other than an obstetrician. But there have been "few studies" on the effect of drugs on women or their infants; currently, most pharmaceutical companies "avoid" clinical trials with pregnant women, opting instead to perform birth defect studies on animals. Though "[w]orry is understandable" because of the thalidomide "catastrophe" in the 1960s, untreated illnesses, such as depression, epilepsy, hypertension and asthma, can be a "clear risk" to both the woman and her child. Labeling requirements will not address the "underlying problem" of the lack of clinical research, said the FDA's Dr. Sandra Kweder. "If most pregnant women knew how little information there is ... they would be greatly surprised," she added (Neergaard, AP/Contra Costa Times, 12/18).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.