FDA Reviews Pregnancy and Pain Med Studies

The U.S. Food and Drug Administration (FDA) issued a safety announcement on January 9 regarding the use of prescription and over-the-counter (OTC) pain medications in pregnant women. It concluded that it cannot make any recommendations on the topic based on the studies in the literature, which are “too limited” according to the agency.

The studies involved nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen.

The FDA reviewed five studies on the risk of miscarriage in the first 20 weeks of pregnancy among women who took prescription NSAIDs, such as ibuprofen and naproxen. Two studies were also reviewed that looked at the risk of brain, spine, or spinal cord birth defects in babies born to women who took opioids, including oxycodone and hydrocodone, during their first trimester of pregnancy. Finally, one study on the risk of attention deficit hyperactivity disorder in children born to women who took acetaminophen in both OTC and prescription products, including medications used for colds and allergies at any time during their pregnancy was also included in the analysis.

According to the FDA, these studies had “potential limitations in their designs; sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions.”

Its recommendations, therefore, will remain the same, according to the announcement.  

The FDA says that the use of pain medications during pregnancy should be carefully considered, and pregnant women should not take any prescription or OTC medications without discussing it with their healthcare providers beforehand. Further, it asks healthcare professionals to continue following the existing recommendations included the current drug labels when prescribing pain medicines to these patients.

-Meredith Edwards White

Reference:

1. U.S. Food and Drug Administration. FDA has reviewed possible risks of pain medicine use during pregnancy. www.fda.gov. 2015 Jan 9.