A “Money Blind” for Research into Maternal-Fetal Medication Risk?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that all of the studies had “potential limitations in their designs” and that “sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions.” As a result, the FDA chose not to update its current recommendations. The agency emphasized, though, that the use of pain medication should be “carefully considered” by pregnant women and their physicians.

One of the reports that triggered the FDA’s review was no doubt this study, published in JAMA in April 2014, which found an association between prenatal exposure to acetaminophen and a higher risk of developing attention deficit hyperactivity disorder. The study led to headlines like Acetaminophen Use While Pregnant Leads to ADHD, Study Says and Mom’s Tylenol Use, Dad’s Age Are Latest Suspects on ADHD Front. At the New York Times’ Motherlode, KJ Dell’Antonia wrote: “If there is a pregnant woman out there willing to take Tylenol after reading this research — or just the associated headlines — I’d be surprised.” But there are serious risks associated with other pain medications, too. Tylenol has long been considered a relatively safe option. Even white-knuckling it is not risk free. As the FDA pointed out in its announcement, untreated severe and persistent pain increases the change that a pregnant woman will develop anxiety, depression, and high blood pressure.

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