NSAIDs Marketed In US Will Have Stronger Label Warning About Risks During Late Pregnancy

In Drug Safety Communication, FDA says it is requiring labeling changes for Rx as well as OTC NSAIDs due to risk of rare but serious kidney problems in an unborn baby.

Basic Care

Manufacturers of OTC NSAIDs marketed in the US will be required to change labeling to more strongly warn against using the drugs during the last three months of pregnancy because the ingredients may cause problems in the unborn child or complications during delivery.

The Food and Drug Administration on 15 October announced in a Drug Safety Communication that it is requiring labeling changes...

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