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Executive Summary

THEOPHYLLINE OTC BAN SOUGHT BY TRIAL LAWYERS as part of Oct. 22 petition to FDA. The Association of Trial Lawyers of America maintained in its filing with FDA that "several experienced physicians who were interviewed by our staff were completely unaware that theophylline is contained in several over-the-counter medications, and all were concerned that the availability of OTC forms constituted a danger to consumers." ATLA received support from a physician specialty group in an Oct. 31 position statement from the American College of Allergy and Immunology. The allergists stated that "because of the need for monitoring blood levels, we believe all drugs containing theophylline should be available by prescription only." Theophylline's continued OTC status already appears tenuous. OTC theophylline as a single ingredient was not included among Category I (safe and effective) bronchodilators in FDA's 1986 final monograph for that class of products ("The Pink Sheet" Oct. 6, 1986, T&G 9). Combinations of theophylline and other ingredients were placed in Category II (no safety or efficacy proof) under a tentative final monograph (TFM) for cough/cold combination products issued in August 1988 ("The Pink Sheet" Aug. 15, 1988, p. 9). FDA action on the theophylline combo status, however, does not appear to be imminent. FDA's agenda of upcoming regulatory actions, published in the Oct. 29 Federal Register, gives no estimated date for the final cough/cold combination products monograph. The agency also indicates that there are no current plans for a separate statement about theophylline products prior to the publication of the final monograph. While the trial lawyers' campaign against OTC theophylline may in effect only be hastening the removal of products already headed off the market, it could pose a more serious long-term problem for the OTC industry by continuing to sour the climate for future OTC switches -- especially in the cough/cold/asthma categories. There are a number of potentially significant switches in that field including several for asthma and allergy: cromolyn sodium, albuterol, and terfenadine. Against the background of failed switches in the bronchodilator and respiratory products class (promethazine and metaproterenol), those other switches may be difficult to effect. Theodore W. Rall, PhD, Professor of Pharmacology at the University of Virginia Medical School appeared at the Oct. 30 ATLA press conference and spoke out against use of theophylline without physician supervision. Noting that theophylline has a narrow therapeutic range, he contended that the ingredient ranks among the top three medications that are "the most dangerous and difficult to use on a chronic basis." He declared that "it is unconscionable to have a drug as dangerous as theophylline being spread in the community without supervision." ATLA's petition to FDA indicates that there have been "26 incidents of theophylline-caused injury for which ATLA members have provided legal representation." The Nonprescription Drug Manufacturers Association maintained that no adverse reactions have been tied to OTC use of the ingredient. In an Oct. 30 statement, NDMA said: "We know of no reports of serious adverse effects caused by OTC products containing theophylline similar to those reported by ATLA." NDMA observed that theophylline products have been available OTC for 35 years.



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