Pregnant women should avoid a group of common painkillers, including Advil and Aleve, in the last four months of pregnancy, federal health officials said Thursday, extending the three-month warning.
The Food and Drug Administration has said that medicines to reduce fever and pain can cause a rare but serious complication that can harm the fetus. They can lead to kidney problems in the fetus, which can lead to low levels of amniotic fluid that fills the womb.
The warning applies to a family of anti-inflammatory medicines, which includes both over-the-counter medicines such as ibuprofen and prescription medicines such as Celebrex. Pills and tablets are among the most commonly taken drugs in the United States and include hundreds of generic aids for colds, flu and sleep, which often combine multiple pharmaceutical ingredients.
FDA labeling already warns that they should be avoided during the last three months of pregnancy because of the risk of other complications.
As an exception, the FDA said the new warning did not apply to low-dose aspirin when recommended by a doctor.
Federal regulators said they decided to extend the warning after finding 35 cases of amniotic fluid problems reported to the FDA and reviewing similar examples in published studies. The use of painkillers reduces amniotic fluid in just two days, in some cases, the FDA said. In general, the problem reversed three to six days after the women stopped taking the medication.
Women who are unsure if their medications contain medications should talk to a doctor or pharmacist, the agency said.
The industry group of over-the-counter drug manufacturers said the companies “will work with the FDA to update the labels accordingly,”
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