Physicians seeking greater clarity about the safe prescribing of pain medications during pregnancy won’t get it from the Food and Drug Administration.
In a safety announcement issued Jan. 9, the FDA informed physicians and patients that it was unable to make any new recommendations about the use of nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen in pregnant women because the existing medical literature is “too limited.”
FDA officials advised physicians to continue to talk with patients about the risks and benefits of analgesics during pregnancy and to follow recommendations in current drug labels for use during pregnancy. For example, current labeling states that NSAIDs should not be used in the third trimester because of the risk of premature closure of the ductus arteriosus in the fetus.
The agency reviewed the medical literature following safety concerns about the use of both over-the-counter and prescription pain medication by pregnant women. The FDA specifically considered prescription NSAIDs and the risk of miscarriage in the first half of pregnancy; opioids and the risk of birth defects following first trimester use; and over-the-counter and prescription acetaminophen use and the risk of attention deficit hyperactivity disorder.
Some of the studies had potential limitations in their designs, while in other cases the accumulated studies on a topic had conflicting results, according to the FDA. “As a result, our recommendations on how pain medications are used during pregnancy will remain the same at this time,” FDA officials wrote in the safety announcement.
Agency officials said they plan to continue to monitor the use of pain medication in pregnant women and will update the public as new safety data becomes available.
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