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OTC ASPIRIN WARNING ON THIRD TRIMESTER USE WILL BE REQUIRED

Executive Summary

OTC ASPIRIN WARNING ON THIRD TRIMESTER USE WILL BE REQUIRED by FDA under a final regulation that the agency hopes to issue "in the next several months," FDA told California Health and Welfare Agency Undersecretary Thomas Warriner in a March 29 letter. The letter was written in anticipation of the April 6 meeting of the state's Scientific Advisory Panel, at which the panel was scheduled to address aspirin warnings under its Proposition 65 initiative. "In the near future, the FDA intends to publish a final regulation requiring...a third trimester pregnancy warning...on all OTC aspirin drug products," FDA Acting Commissioner Benson told the state. "We intend to act expeditiously to require this new pregnancy warning on aspirin products and hope to publish a final rule in the next several months." * Benson said the agency is "currently considering" requiring use of the same warning statement that appears on ibuprofen products: "It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by your doctor because it may cause problems in the unborn child or complications during delivery." The agency intends to make the upcoming aspirin regulation effective on the date of publication. "Manufacturers of affected products would then be allowed up to one year to make the labeling changes," Benson noted. That timeframe would eliminate different federal and state labeling requirements. If California decides to add aspirin to its list of agents with potential reproductive toxicity, aspirin manufacturers would have until at least July 1991 to comply with state labeling requirements. California previously has said that a warning based on the ibuprofen statement would be acceptable. The ibuprofen warning differs somewhat from the third trimester aspirin warning FDA had proposed in 1988 under its tentative final monograph for OTC internal analgesics. In that rulemaking, the agency proposed labeling aspirin products with the warning statement: "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 the mother and child." * In anticipation of the probable inclusion of aspirin in California's Prop 65 list, the Nonprescription Drug Manufacturers Association wrote FDA on March 16 asking that the agency implement a third trimester aspirin warning requirement prior to publication of the final monograph for internal analgesics. NDMA, however, suggested a slightly more general warning than the ibuprofen-modeled warning being favored by FDA. The association's suggested warning statement reads: "Do not use this product during the last three months of pregnancy unless advised to do so by a doctor because it may cause problems during delivery." The association previously had opposed the third trimester warning that FDA proposed in the internal analgesic TFM, arguing that it was confusing and might lead consumers to believe that "there may be circumstances in which a woman in the last trimester of pregnancy should take aspirin when directed to do so by a doctor" ("The Pink Sheet" May 22, T&G-2). California's Scientific Advisory Panel was originally scheduled to make a decision on the listing of aspirin at its October 1989 meeting. The group delayed the decision to allow the Aspirin Foundation of America to present final results of an aspirin study it had funded. The final results, which were submitted to FDA and presented at the April 6 meeting, support a lack of an association between aspirin and bleeding complications in pregnancy. The study, based on data in the National Collaborative Perinatal Project, compared birth outcomes of 9,000 women who had taken aspirin within the last 10 days of delivery to women who had not been exposed to aspirin. The study authors (Robert Brent, MD/PhD, Thomas Jefferson University, et al.) found "no evidence to suggest that aspirin taken in the usual dosages during the last 10 days of pregnancy increases bleeding tendencies in either the mother or the child," according to a summary of the study results. The authors also looked at premature infants in the NCPP database to compare bleeding tendencies in the exposed and non-exposed infants. "Again, there was no indication that aspirin exposure within the last 10 days of pregnancy aggravated the bleeding tendencies of the premature infants," the summary states. Brent et al. had previously used the database to examine birth outcomes in women who took aspirin during the last trimester or during the last month of pregnancy. Those analyses "found no evidence whatsoever to support a possible association between aspirin ingestion at normal dose and increased length of gestation, stillbirth, maternal bleeding, or neonatal bleeding," according to the summary. Those study results were reported at the Scientific Advisory Panel's Oct. 20, 1989 meeting.
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