Pregnancy warning extended for common pain relievers, FDA says

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Fox News correspondent Laura Ingle reports.

The FDA said it will require common pain reliever medicines to change their labels to reflect warnings for women who are 20 weeks or later into pregnancy, bumping up the previously established warnings by a month.

The regulatory agency said taking these nonsteroidal anti-inflammatory drugs at 20 weeks gestation or later in the pregnancy can cause rare but serious kidney problems in the unborn baby, leading to low levels of amniotic fluid and possible pregnancy-related complications.

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The medications that require these updated changes include ibuprofen, naproxen, diclofenac and celecoxib, which are offered in both prescription and over-the-counter form. They are most commonly used to treat fever, colds, muscle aches and pain. The changes reflect a change in policy, which previously warned women to avoid taking these medications during the last three months of pregnancy.  

Low-dose aspirin, however, will not be included in the changes as it may be “an important treatment for some women during pregnancy,” and should be taken under the direction of health care provider, according to the FDA.

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“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a news release posted Thursday. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”  

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The changes come after the FDA received 35 reports of a decrease in amniotic fluid related to taking NSAIDs. The agency said some cases saw the use of the pain relievers reduce amniotic fluid in as little as two days, although the problem typically reversed itself three to six days after the women stopped taking the medicines, according to the Associated Press.