Aspirin Label to Warn of Danger in Late Pregnancy

In a move that will strengthen warning labels on aspirin, a state scientific advisory panel voted Friday to place the non-prescription drug on California’s list of chemicals known to cause reproductive harm.

Despite strong objections from the aspirin industry, Gov. George Deukmejian’s panel of experts concluded that aspirin can cause excessive bleeding in a mother or her fetus if taken during the last three months of pregnancy.

With the panel’s action, aspirin will go on the list of chemicals governed by Proposition 65, the state anti-toxics law, and warnings will be required by July 1, 1991, that alert pregnant women to the danger of taking the pain reliever during their third trimester.

The federal Food and Drug Administration already requires a label on aspirin that warns pregnant women not to take the drug without a physician’s approval and a tougher warning has been under consideration by the agency for more than a decade.

In anticipation of the state action, the FDA notified state officials earlier this week that it will soon order manufacturers to provide the stronger warning on products containing aspirin. But the Proposition 65 panel agreed that it should require the warnings on aspirin sold in California despite the FDA’s pledge to act.

Scientists representing the industry-backed Aspirin Foundation urged the panel not to list aspirin, contending that the designation of the drug as a cause of reproductive harm would panic pregnant women and result in needless abortions.

They argued that a recent study sponsored by aspirin manufacturers found no indication of the bleeding complications discovered in earlier studies.

But state scientists criticized the industry study as flawed because it relied on incomplete data from 30 years ago, and the panel rejected the manufacturers’ plea.

Studies have shown that in some cases aspirin can cause complications for the mother during delivery or bleeding in the brain of the fetus. However, a recent study said that the drug in low doses can prevent a potentially fatal form of high blood pressure in pregnant women.

The warning that would be required under either the state or federal action is similar to that already required for other over-the-counter drugs containing the pain reliever ibuprofen.

Under wording proposed by the FDA, aspirin labels would say: “It is especially important not to use aspirin during the last 3 months of pregnancy unless specifically directed to do so by your doctor because it may cause problems in the unborn child or complications during pregnancy.”