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FDA ISSUES ALERT ON ANTIHISTAMINE DRUG HISMANAL

 FDA ISSUES ALERT ON ANTIHISTAMINE DRUG HISMANAL
 WASHINGTON, Oct. 28 /PRNewswire/ -- The Food and Drug


Administration (FDA) today warned doctors against the use of the prescription antihistamine drug Hismanal (astemizole) in combination with the anti-fungal drugs ketoconazole or itraconazole or the antibiotic drug erythromycin.
 Janssen Pharmaceutica, manufacturer of Hismanal, has agreed to send a "Dear Doctor" letter to physicians and other health professionals cautioning them about the risk of serious cardiac arrhythmias -- heart rhythm abnormalities -- in patients who used any of these drugs with Hismanal.
 Hismanal is a non-sedating antihistamine prescribed for the treatment of seasonal allergies and hives. FDA in July had issued a warning about exceeding Hismanal's recommended dose of 10 mg (one tablet) per day because of the increased risk of cardiac arrhythmias. Hismanal is known to cause cardiac arrhythmias when present at excessive levels in the blood.
 FDA recently received reports of serious arrhythmias in two patients who took Hismanal with erythromycin, or erythromycin plus ketoconazole, alerting FDA to a possible interaction between Hismanal and these drugs, as a cause of arrhythmias. Subsequently, Janssen submitted preliminary information indicating that blood levels of Hismanal are greatly increased in patients taking ketoconazole. Itraconazole, recently approved by FDA, was included in the warning primarily because of its chemical and pharmacologic similarity to ketoconazole.
 FDA issued a similar warning in July for other non-sedating antihistamine drug products, Seldane and Seldane-D.
 "Because of the potentially serious nature of these interactions, we must be extremely cautious, and we urge doctors and patients to avoid combining these drugs," said FDA Commissioner David A. Kessler, M.D.
 The new labeling for Hismanal includes the following boxed warning: "Concomitant administration of astemizole (Hismanal) with ketoconazole tablets, itraconazole or erythromycin is contraindicated."
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 10/28/92
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Monica Revelle or Susan Cruzan of the Food and Drug Administration, 301-443-3285/ CO: Food and Drug Administration; Janssen Pharmaceutica ST: District of Columbia IN: MTC SU:


MH -- DC030 -- 6215 10/28/92 16:24 EST
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Date:Oct 28, 1992
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