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Executive Summary

The following is a facsimile of a letter from FDA Office of Drug Research and Review Director Robert Temple, MD, concerning beta-blocker labeling. The letter comments on points contained in a story on FDA's approval of Glaxo/Schering's alpha/beta blocker labetalol ("The Pink Sheet" Aug. 13, p. 4). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service, National Institutes of Health, Bethesda, Maryland 20205 In your article on labetalol (August 13, 1984) you note that the drug's warnings for exacerbation of ischemic heart disease following withdrawal and against use in patients with bronchospastic disease are less strongly stated than in standard beta-blocker labeling. That was not intended and I do not believe it is so. Beta-blockers approved only for hypertension (labetalol, pindolol, atenolol, and metoprolol, until recently) do not carry a boxed warning about risks of sudden withdrawal because the withdrawal syndrome has been seen in dangerous form only in patients with angina. The beta-blockers with an angina claim (or a post-infarction claim) carry the boxed version (propranolol, nadolol, timolol) because they are specifically intended for use in coronary artery disease patients. This particular distinction may well be out-moded, if beta-blockers are in practice used interchangeably, but it is the basis for the current differences in labeling, not any perceived differences among the drugs. Labetalol bears the usual beta-blocker contraindication to use in asthmatics; only metoprolol and atenolol, the cardioselective agents, lack this. But the beta-blockers are not contraindicated for use in all patients with bronchospasm and contain only a warning regarding use in "non-allergic bronchospasm"; it may be that a better term here would be chronic obstructive pulmonary disease. In any case, labetalol's labeling is similar to that of other non-selective beta-blockers.

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