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OTC USE OF THEOPHYLLINE COUGH/COLD COMBINATIONS: FDA WILL DECIDE THIS YEAR IF OTC MARKETING SHOULD CONTINUE -- AGENCY RESPONDS TO TRIAL LAWYER PETITION

Executive Summary

FDA will decide this year whether cough/cold products in combination with theophylline should be marketed OTC, the agency told the Association of Trial Lawyers of America in a Dec. 7 letter. FDA will also consider requiring patient package inserts to accompany OTC theophylline products. Peck was responding to a petition filed in October by ATLA that seeks an FDA ban on OTC marketing of theophylline-containing products ("The Pink Sheet" Nov. 5, T&G-12). In its petition, ATLA maintained that physicians who were interviewed were unaware that theophylline is contained in OTC products and were concerned that OTC availability "constituted a danger to consumers." Combinations of theophylline were classified as Category II (no proof of safety or efficacy) under a tentative final monograph for cough/cold combination products published in August 1988. Since late 1976, FDA has banned use of theophylline as a single agent in OTC products. Peck also responded to ATLA's assertion that there have been "26 incidents of theophylline-caused injury for which ATLA members have provided legal representation." Peck said: "In the absence of more detailed information regarding the medical situation, dosage administered, plasma levels observed, and possible confounding factors involved in each case, it is not possible for us to comment on the implications of these events with regard to the safety of theophylline; or indeed to be confident that they represent adverse effects of theophylline." The FDAer noted that "a number of these events occurred in very young children or elderly patients, two groups in which close monitoring is common practice and who are also at risk of anoxic death and injury due to status asthmaticus itself." Also five of the cases occurred in the 1970s when information on "optimal management" of such patients may not have been available. Peck said that he will review "an updated summary of all such cases." FDA's response notes that "a considerable body of evidence has been accumulated in the more than 50 years that theophylline has been marketed in the United States, and the incidence of serious adverse reactions has been quite low." Peck pointed out that "although the toxicity of excessive theophylline levels is real, it is well recognized and the risk may be avoided quite readily through proper dose selection and monitoring." Peck added that "reliable tests for measurement of theophylline blood levels are widely available for use in hospital and commercial laboratories, as well as the physician's office." In response to ATLA's suggestion that FDA encourage physicians to use alternatives to theophylline, Peck said that "it is not within the purview of the agency to advise physicians regarding selection among approved products." ATLA also asked FDA to require both prescription and OTC theophylline products be fully described in the Physicians' Desk Reference. FDA said that it "cannot require inclusion of a product's labeling in the PDR." Labeling for single agent theophylline products has "complete safety and dosing information;" however, the agency plans to review the guidelines for labeling of theophylline products and labeling of all such prescription products "to ensure that all products are brought into compliance with the guidelines." Publicity about theophylline's safety concerns seems to be growing four months after ATLA filed its petition. ABC News "PrimeTime Live" on Feb. 7 ran a feature called "The Wrong Dose," which included interviews with several people involved in the original ATLA press conference. Also interviewed were the parents of Anthony Blake and their lawyer Jerome Mirza, who recently won a $ 77.8 mil. jury award in a theophylline case ("The Pink Sheet" Nov. 26, In Brief). Appearing on the show, Peck said "the safe and effective administration of theophylline in the individual patient is the physician's responsibility [but] FDA and the drug manufacturer play an important role."
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