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Executive Summary

FDA REVIEW OF OTC ASPIRIN FOR HEART ATTACK, STROKE prevention is ongoing and will require additiona input from the Cardio-Renal Drugs Advisory Committee, Office of OTC Drug Evaluation Acting Director Paula Botstein, MD, testified at an April 1 congressional hearing on the OTC Review and other protracted agency rulemaking efforts. Speaking at an April 1 hearing before the House Energy & Commerce/Health subcommittee, Botstein said that FDA is "right in the middle of evaluating [OTC aspirin for the prevention of heart attack and stroke] now." The agency has "been to the Cardio-Renal Advisory Committee, and we will go again." At an October 1989 meeting, the committee recommended that professional labeling for aspirin carry a limited claim that the drug can reduce heart attack chances only in high-risk patients. The committee chairman at the time, Craig Pratt, MD, Baylor University, commented that there was "not much enthusiasm for awarding the indication" based on available data. The committee also discussed aspirin to prevent recurrence of stroke in December 1990, when it recommended approval of Syntex' Ticlid (ticlopidine) for the indication in patients intolerant to aspirin. Botstein's answer came in reply to a question by Rep. Wyden (D-Ore.) as to when FDA will inform the public about seeing a physician before taking aspirin chronically and the importance of low-dose administration. "When will the public know, for example, when they ought to see an MD and what the latest research is as it relates to low doses?" Wyden asked. The FDAer said the agency's OTC internal analgesic monograph will not include information about new uses of aspirin related to heart attack and stroke. "The OTC Internal Analgesic Monograph is not the place to address these uses of aspirin," Botstein said. The reason is that they "are not things for which aspirin was used all these many years ago when the monograph system started," she said. Petitions must be filed to add new uses to monographs. Wyden asked why FDA cannot expedite publication of a "monograph in the next few months and stipulate that aspirin labels should" advise patients to "see a physician before starting daily aspirin therapy" and to recommend a specific, low daily dosage "based on FDA's analysis of the latest large research trials." FDA is "in the middle, right now, of looking at this," Botstein said, but the agency "will redouble our efforts." Because "these uses of aspirin are not in the final monograph system," Botstein said, FDA "will need to publish for comment special Federal Register notices and proposals for indications for aspirin for these cardiovascular uses." In a March 31 response to a Feb. 21 letter from Wyden, FDA said it is "concerned that long-term use of OTC drug products containing aspirin may cause adverse effects." The agency noted that it "has issued a number of warnings to alert consumers not to use aspirin products for longer periods of time than the labeling recommends without consulting a physician." The letter, signed by Associate Commissioner for Legislative Affairs Marc Scheineson, also reports that FDA is considering label warnings regarding liver toxicity associated with normal doses of acetaminophen. FDA noted that it is "aware of the association of human liver toxicity to acetaminophen overdose" and that it proposed an overdose warning for OTC acetaminophen labeling in 1988. The letter further reports that FDA "currently is evaluating cases of acetaminophen's link to non-overdose enhanced liver toxicity in formulating final label warning requirements" for the appropriate monographs. Asked by Wyden about phenylpropanolamine in OTC diet aids, Center for Drug Evaluation & Research Director Carl Peck, MD, testified at the hearing that FDA has established a "target date for publishing the tentative final monograph [in] December of this year." Peck added that FDA is "hard at work taking into account new data that was brought to our attention at a public hearing" on adverse effects of the OTC ingredient last year ("The Pink Sheet" May 13, 1991, p. 7).

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