Pregnant Women Warned on Aspirin

The Food and Drug Administration on Monday announced stronger warnings against the use of over-the-counter aspirin products by women in the last three months of pregnancy unless directed by a physician.

The agency said the stronger warning on labels is being required because aspirin can affect fetal circulation and uterine contraction.

The new warning must immediately follow a more general caution telling pregnant women and nursing mothers to check with a health professional before using aspirin or any other drug.

The FDA said manufacturers have 12 months to implement the label changes, recommended by an advisory panel of non-government medical experts. The regulation will be published Thursday in the Federal Register.

A similar warning is already required on non-prescription products containing ibuprofen, another pain-relieving ingredient. Aspirin and ibuprofen have similar pharmacologic effects.

The new warning must read:

“It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.”