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Executive Summary

FISONS WITHDRAWING SOMOPHYLLIN THEOPHYLLINE PRODUCTS from the U.S.; marketing for the asthma product will cease by the end of November. The company is halting the sale of the bronchodilators for "commercial reasons," a spokesperson said. The product withdrawal comes at a time when the Association of Trial Lawyers of America (ATLA) is beginning to publicize alleged side effects from theophylline use. A lawsuit involving one of the Somophyllin dosages was mentioned at an Oct. 30 press conference held by ATLA in Washington, D.C. ATLA held the press conference to announce the filing of a petition with FDA to ban OTC use of theophylline and to seek added warnings for the prescription versions (see preceding item). ATLA described its efforts against theophylline as part of an "ongoing ATLA ALERT consumer protection program." To dramatize potential theophylline effects at the press conference, ATLA included statements by the father of a seven-year-old girl who took theophylline and suffered brain damage, and by the lawyer who represented that family in a liability suit versus Fisons. That suit was settled in April of this year. ATLA attached two Fisons documents from 1981 and 1986 warning about theophylline side effects as part of the association's filing with FDA. The Fisons documents are a 1981 letter to physicians cautioning about theophylline dosing for children during viral infections and a 1985 internal memorandum on increasing theophylline use and toxicity reports. Ironically, the two examples of correspondence used against Fisons in the liability suit appear to reflect Fisons' interest in promoting its cromolyn sodium products (Intal) in lieu of theophylline. The 1981 letter to physicians, for example, summarizes a report on factors affecting the absorption of the drug. The "Dear Doctor" letter ends with a postscript referring to Intal: "Just a reminder that there is a drug available which has comparable efficacy to theophylline in chronic asthma, is not metabolized, acts locally, and has a much wider therapeutic index and a low incidence of side effects." Similarly, the 1985 internal memo warns of increased theophylline use and toxicity reports and says those reports provide "strong justification for our corporate decision to cease promotional activities with our theophylline line of products." ATLA requests that prescription theophylline products carry stronger bold-face warnings of potential neurological damage and package inserts for patients. Schering-Plough, manufacturer of Theo-Dur, called the ATLA petition and press conference "self-serving publicity campaigns" in an Oct. 29 position statement. Schering-Plough held a press briefing immediately following the ATLA conference. Schering-Plough VP-Marketing David Pernock stated that "theophylline is a product that is very safe and effective for the treatment of asthma, and it is one that should be in the hands of skilled physicians. When used properly, its safety record is very admirable." Pernock indicated that, out of approximately 60 mil. prescriptions filled with Theo-Dur since 1985, the incidence of serious adverse drug events reported to FDA has been 1.3 reports per 100,000 prescriptions.

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