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October 26, 1994

Examining Product Risk in Context: The Case of Zomepirac-Reply

Author Affiliations

Ortho-McNeil Pharmaceutical Raritan, NJ

JAMA. 1994;272(16):1252-1253. doi:10.1001/jama.1994.03520160036028

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In Reply.  —Dr Spielberg suggests that the company's "Dear Doctor" letter of April 9, 1982, describing reports of anaphylactic reactions to zomepirac was inadequate because it stated that those reactions were similar to those reported in association with the use of other nonsteroidal anti-inflammatory drugs.After the marketing of zomepirac in 1980, reports of adverse experiences resembling anaphylactic reactions were reported to Ortho-McNeil Pharmaceutical. A number of those reports occurred in aspirin-sensitive patients for whom zomepirac and other nonsteroidal anti-inflammatory drugs are contraindicated. These were promptly reported to the FDA. In close collaboration with the FDA, the company drafted and issued the Dear Doctor letter to draw attention to these reactions and provide additional information to physicians so that zomepirac could be properly prescribed.Advertising campaigns with appropriate fair balance have always been acceptable forms of promotion for approved and marketed medications. However, because of continued reports of anaphylactic reactions,

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