FDA Urges Continued Caution for Pain Meds in Pregnancy

Megan Brooks

January 09, 2015

In a drug safety communication issued today, the US Food and Drug Administration (FDA) says it is aware of recent reports "questioning" the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy, but that it lacks adequate studies to change current recommendations.

The benefits and risks of using prescription and OTC pain medicines during pregnancy need to be carefully weighed, the FDA reminds healthcare providers in the communication.

The FDA evaluated published studies on the following:

  • Prescription nonsteroidal anti-inflammatory drugs (eg, ibuprofen, naproxen, diclofenac, and celecoxib) and the risk for miscarriage in the first half of pregnancy.

  • Opioids (eg, oxycodone, hydrocodone, hydromorphone, morphine, and codeine) and the risk for birth defects of the brain, spine, or spinal cord in infants born to women who took these products during the first trimester of pregnancy.

  • Acetaminophen in both OTC and prescription products and the risk for attention-deficit/hyperactivity disorder in children born to women who took this medicine at any time during pregnancy.

According to the FDA, the studies contain too little information to make any recommendations based on these studies at this time. "Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. We urge pregnant women to always discuss all medicines with their health care professionals before using them," the agency notes.

All the studies have potential limitations in their designs, and some contain conflicting results that prevent drawing reliable conclusions, the FDA says. "As a result, our recommendations on how pain medicines are used during pregnancy will remain the same at this time."

The agency advises pregnant women to "always consult with their health care professional before taking any prescription or OTC medicine. Women taking pain medicines who are considering becoming pregnant should also consult with their health care professionals to discuss the risks and benefits of pain medicine use. Health care professionals should continue to follow the recommendations in the drug labels when prescribing pain medicines to pregnant patients."

More information on today's announcement is available on the FDA website.

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