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BRISTOL-MYERS BUFFERIN STUDIES SUPPORT OTC CLAIM OF REDUCED STOMACH DISTRESS WHEN USED SHORT-TERM, FDA SAYS; CHRONIC USE CLAIM NEEDS FURTHER DATA

Executive Summary

FDA appears set to allow OTC stomach protection labeling claims for Bufferin and similar buffered aspirin products when used short-term. In a March 7 letter to Bristol-Myers Squibb, FDA OTC Drug Evaluation Division Director William Gilbertson told the firm that its Bufferin studies "provide adequate evidence of the effectiveness of your tri-buffered aspirin formulations in decreasing the incidence of aspirin-related stomach upset in subjects with a history of gastrointestinal intolerance to aspirin under the conditions of the studies (up to three days dosing with 650 to 1,000 mg four times a day) and would support a claim to this effect." Before the buffered aspirin products can be included in the monograph, however, FDA said it will need "information on the complete composition of the tri-buffered Bufferin formulations and placebo used in the studies together with the information on your release specifications." FDA said the formulation information is necessary "for the agency to be able to assess the contribution of this unique formulation to the drug products' advantage observed in the clinical studies and to determine if it would be possible to establish criteria, e.g., similar acid neutralizing capacity and dissolution rates, for inclusion into the monograph that would allow other buffered aspirin drug products meeting these criteria to make a claim for decreased aspirin-related stomach upset." * Bristol-Myers submitted the studies between August 1987 and December 1988 in support of a Category I stomach protection claim in the OTC monograph for internal analgesics. The studies tested Bristol-Myers' three buffered aspirin products: Tri-Buffered Bufferin, Extra Strength Tri-Buffered Bufferin, and Arthritis Strength Tri-Buffered Bufferin. The internal analgesic tentative final monograph had included buffered aspirin stomach protection claims in Category III. The Category III claim read: "Provides ingredients that may prevent the stomach distress that plain aspirin occasionally causes but should not be taken by certain individuals as cautioned elsewhere on the label." Based on Bristol-Myers' studies, the agency is proposing a modified labeling claim: "Provides (or contains) ingredients that decrease the frequency of the stomach distress sometimes caused by plain aspirin. This product should not be taken by individuals with a history of stomach or intestinal ulcers or bleeding disorders, or on anticoagulant therapy, as noted elsewhere on the label." FDA noted that, because of the "limited duration of the studies," the labeling "claim would only apply to the product's short-term use." Because existing data address only the short-term symptomatic effects of the buffered aspirin products, the agency is encouraging Bristol-Myers to conduct two additional studies. The agency is requesting a long-term study to evaluate protective benefits for longer than three days and an endoscopic study to evaluate whether buffered aspirin is safer for the gastric mucosa or only provides symptomatic relief. "To date, it has not been demonstrated that there is good correlation between the extent or severity of subjective symptoms and the damage to the gastric mucosa that drug products such as these can cause," FDA explained. "Therefore, these studies shed no light on the relative safety of your formulations with regard to aspirin-induced damage to the gastric mucosa." The agency, Gilbertson continued, "strongly" encourages the company "to conduct an endoscopic study and another clinical study of longer duration to obtain information on these important issues."
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