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Executive Summary

OTC ASPIRIN EXPANDED THIRD TRIMESTER PREGNANCY WARNING REQUIRED under an FDA final rule published in the Federal Register July 5. 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 newborn child or complications during delivery." The warning, which must appear in boldface, capital letters, is to be added to the general pregnancy/nursing warning statement already required by the agency: "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product." The rule will become effective Aug. 6; manufacturers will have until July 5, 1991 to comply with the new requirements. FDA originally proposed a more specific warning in the Nov. 16, 1988 Tentative Final Monograph for OTC analgesics, which read: "do not take this product during the last three months of pregnancy unless directed by a doctor. Aspirin taken near the time of delivery may cause bleeding problems in both mother and child." In changing the TFM warning's reference to "bleeding problems," the agency notes that "aspirin used in the third trimester of pregnancy poses some potential risks, only one of which is bleeding." Agency concerns include aspirin's potential effects on "the hemostatic mechanisms in the newborn...increased maternal blood loss...[and] multiple effects of prostaglandin inhibition on the fetus and on delivery." The warning specified by the final rule matches the warning that has been required for more than five years on OTC products containing ibuprofen. Addressing the corresponding warning statements, the rule states that "the agency now believes that having different warnings on OTC drug products containing these ingredients could cause consumers to perceive that there is a difference in the safety of using these ingredients during the third trimester of pregnancy when, in fact, there is no established significant safety difference." FDA noted that "both aspirin and ibuprofen are members of a class of drug ingredients known as non-steroidal anti-inflammatory drugs...Aspirin and the other members of this class share similar effects on prostoglandin synthesis, and their effects on pregnancy are similar." The new warning forestalls the potential for a dichotomy between state and federal regulations that arose earlier this year when California considered requiring a strengthened aspirin pregnancy warning of its own under the state's "Proposition 65" initiative to label consumer products with potential reproductive toxicity ("The Pink Sheet" April 9, T&G-12). FDA Acting Commissioner Benson informed California's Scientific Advisory Panel in an April letter that FDA would soon be strengthening the third trimester warning. California officially included aspirin in its list of products eligible for warnings under Prop. 65 on July 1. The FDA warning requirement will satisfy the California requirement, a California program spokesperson said. The deadline for compliance with the aspirin warning rule in California is July 1, 1991, four days before the federal rule's deadline. Nothing that there are still "other matters pending" in deliberations on the tentative final monograph, the agency said it is "finalizing this warning for OTC aspirin-containing drug products now, in order to ensure that consumers have adequate information concerning the use of these products during the third trimester of pregnancy."

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