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ANALGESIC COMBINATIONS' ASSOCIATION WITH CHRONIC RENAL DISEASE

Executive Summary

ANALGESIC COMBINATIONS' ASSOCIATION WITH CHRONIC RENAL DISEASE at low doses is not supported by existing data, the Nonprescription Drug Manufacturers Association (NDMA, formerly the Proprietary Association) said in May 16 comments to FDA. Citing a National Institutes of Health panel's conclusions on analgesic-associated kidney disease, NDMA said it agreed with the panel that "no evidence has been presented to indicate that single antipyretic analgesic drugs cause chronic renal disease when taken in the smaller dosage usually prescribed by physicians or taken for valid medical reasons in doses recommended by the manufacturers." NDMA's comments were in response to the FDA Tentative Final Monograph on Internal Analgesic, Antipyretic and Antirheumatic Drug Products, published last November ("The Pink Sheet" Nov. 21, p. 7). The agency had requested input on the link between combination antipyretic analgesics and kidney disease or chronic renal failure. NDMA's response came less than a week after publication of a study in The New England Journal of Medicine suggesting a link between daily acetaminophen use and chronic renal disease ("The Pink Sheet" May 15, T&G-6). The association told FDA that it disagreed with the NIH panel's recommendation that consideration be given to "limiting OTC drug products to those containing a single antipyretic analgesic agent." The panel found that combination antipyretic analgesics taken in large doses over long periods can cause kidney disease and chronic renal failure. NDMA maintained there was "no evidence presented by the NIH Consensus Conference Statement to indicate that combination antipyretic analgesics cause chronic renal disease when taken in the 'smaller doses' to which the panel refers in relation to single ingredient analgesics." NDMA also referred to a review of epidemiologic research on OTC analgesics and phenacetin conducted by Elizabeth Delzell, who works with Epidemiology Resources Inc. and the New England Epidemiology Institute. Delzell had concluded: "There is insufficient epidemiologic evidence to evaluate the hypothesis that analgesics that do not contain phenacetin cause chronic renal disease, or that phenacetin-containing analgesics have an effect on any form of chronic renal disease other than renal papillary necrosis." FDA cited the final report of the NIH 1984 Consensus Development Conference on Analgesic-Associated Kidney Disease in the tentative final monograph and has included the report in the administrative record for the drug category. NDMA requested that FDA's proposed pregnancy warning regarding analgesic use during pregnancy be eliminated on the basis that consumers may be confused by the wording. The proposed warning reads: "Do not take this product during the last three months of pregnancy unless directed by a doctor. Aspirin taken near the time of delivery may cause bleeding problems in both the mother and child." The association said "the first sentence of the proposed warning could lead a consumer to believe that there may be circumstances in which a woman in the last trimester of pregnancy should take aspirin when directed to do so by a doctor, even though the second portion of the proposed warning says clearly" that aspirin may cause bleeding problems. Rorer, in May 2 comments on the TFM, also called the proposed pregnancy warning confusing. The company added that FDA should permit labeling for use of aspirin in treating arthritis inflammation and pain under the advice of a physician. The use of buffered or antacid/aspirin products should be allowed for relief of aspirin-induced stomach upset, the firm stressed. Rorer said that it will submit to FDA before November 1989 a clinical study supporting the effectiveness of its Ascriptin tabs for this indication. In its submission, NDMA also suggested several alternative "truthful and non-misleading" statements of identity for analgesic, antipyretic and antirheumatic drugs including: "muscular pain reliever"; "toothache pain reliever"; "backache pain reliever"; and "headache pain reliever."
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