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FDA warns about the dangers of common painkillers during pregnancy

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Friday, October 16, 2020 (HealthDay News)-If you are pregnant and think it is safe to take non-steroidal anti-inflammatory drugs (NSAIDs) for pain or pain, think again.

The U.S. Food and Drug Administration warned Thursday that taking these widely used painkillers (such as Advil, Motlin, Alive, and Celebrex) after the 20th week of pregnancy may increase the risk of complications. did.

Specifically, taking the drug causes rare but serious kidney problems in the fetus, lowers amniotic fluid levels, and increases the likelihood of pregnancy complications.

About 20 weeks after pregnancy, the kidneys of the fetus begin to produce most of the amniotic fluid, so kidney problems can cause low levels of this protective solution. According to the FDA, low levels of amniotic fluid usually resolve when pregnant women stop taking NSAIDs.

Authorities said NSAID labeling has ordered women and their health care providers to warn about this risk.

NSAIDs are prescription and over-the-counter drugs (OTCs) such as ibuprofen, naproxen, diclofenac, and celecoxib used to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules do not apply to the use of low-dose aspirin.

“It’s important to understand the benefits and risks of drugs that women may take during pregnancy,” said Dr. Patrizia Cavazzoni, Deputy Director of the FDA’s Center for Drug Evaluation and Research, in an agency news release. It was.

One obstetrician and gynecologist pointed out that over-the-counter NSAIDs can pose the greatest risk to pregnant women.

“Many female patients regularly use ibuprofen for headaches and dysmenorrhea,” said Dr. Jennifer Wu of Lenox Hill Hospital in New York City. “It is very important for these patients to recognize that ibuprofen and other NSAIDs pose a unique risk to pregnant patients.

“The majority of patients may even get these drugs over-the-counter and use them at prescription intensity levels,” Wu added. “Many prescription drugs have pharmacist supervision and warning labels, but over-the-counter drugs lack all of this. Patients also often think that over-the-counter drugs inevitably mean safety. “

FDA warnings are issued after a review of the medical literature and cases reported to the FDA regarding decreased fetal amniotic fluid levels or kidney problems associated with the use of NSAIDs during pregnancy.

For prescription NSAIDs, the new FDA warning recommends limiting use between approximately 20 and 30 weeks of gestation. Prescription information already included a warning not to take NSAIDs about 30 weeks after pregnancy due to the risk of fetal heart disease.

If a healthcare provider believes that NSAIDs are needed between about 20 and 30 weeks of gestation, use should be limited to the lowest possible dose and the shortest possible period, the FDA said.

According to the agency, manufacturers of OTC NSAIDs for adults will make similar updates to their labels.

For more information

The US Food and Drug Administration NSAID..

Source: Dr. Jennifer Wu, Lenox Hill Hospital, New York City.US Food and Drug Administration, News Release, October 15, 2020

Robert Prite

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