The FDA has announced that its review of the evidence surrounding the use of painkillers during pregnancy is inconclusive. None of the studies it reviewed gives enough information for them to change the current recommendations. As a result, it says women should talk about risks and benefits with their doctors before deciding to use painkillers during pregnancy.

Potential Risks

The FDA review of painkiller use during pregnancy focused on some recent studies that seemed to show additional risk associated with painkiller use during pregnancy, including some over-the-counter medications that are often considered “safe” during pregnancy.

Among the potential risks reviewed were:

  • An increased risk of miscarriage in the first half of pregnancy related to the use of prescription nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, and celecoxib
  • Risk of birth defects in the brain, spine, or spinal cord in infants when opioids are used during the first trimester
  • Increased risk of attention deficit/hyperactivity disorder associated with acetaminophen use at any time during pregnancy, including both prescription medication and over-the-counter forms like Tylenol.

The FDA said all the studies that it reviewed had limitations and that none of the studies gave enough information for changing the recommendations. Statistics show that among these medications, the most commonly used in pregnancy is acetaminophen, which may be used in up to 70% of pregnancies. NSAIDs may be used in nearly 30% of pregnancies, including 25% of pregnancies that may be exposed to over-the-counter ibuprofen (Advil) and 4% that are exposed to over-the-counter naproxen (Aleve). About 6% of pregnancies are exposed to prescription opioid medication.

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