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FDA prolongs pregnancy warnings for common painkillers


Washington-Pregnant women should avoid groups of common painkillers, including Advil and Arive, during the last four months of pregnancy, federal health officials said last week, extending the warning from three months.

The Food and Drug Administration said fever and pain-relieving medications can cause rare but serious complications that can harm the unborn baby. They can cause problems with the kidneys of the fetus and can result in low levels of amniotic fluid that fill the uterus.

The warning applies to a family of anti-inflammatory drugs that include both over-the-counter ingredients like ibuprofen and prescription drugs like Celebrex. Pills and tablets are one of the most widely taken medications in the United States and contain hundreds of generic cold, flu, and sleep aids that often combine multiple pharmaceutical ingredients.

The FDA label has already warned that the last three months of pregnancy should be avoided due to the risk of other complications.

With one exception, the FDA said the new warning would not apply to low-dose aspirin if recommended by a doctor.

Federal regulators said they had found 35 cases of amniotic fluid problems reported to the FDA and decided to extend the warning after considering similar cases in a published study. According to the FDA, painkillers can reduce amniotic fluid in just two days. In general, the problem went away 3 to 6 days after the woman stopped taking the drug.

Women who are unsure whether the drug contains the drug should consult a doctor or pharmacist, the agency said.

An industry group of over-the-counter drug manufacturers said in an email that the company “worked with the FDA to update the label accordingly.”

• The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.


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