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FDA ISSUES HISMANAL WARNING

 FDA ISSUES HISMANAL WARNING
 WASHINGTON, July 20 /PRNewswire/ -- The Food and Drug


Administration and Janssen Pharmaceutica, manufacturer of the prescription antihistamine drug Hismanal, today announced that Janssen will inform doctors and other health professionals of cardiovascular risks to patients who exceed the recommended dose.
 Rare cases of serious cardiovascular events, including death, cardiac arrest and arrhythmias, were reported in patients exceeding the recommended dose of 10 mg (one tablet) per day. While the majority of these cardiovascular events have occurred in patients who have greatly exceeded the recommended dose, arrhythmias have occurred at reported doses as low as 20 to 30 mg daily -- two to three times the recommended daily dose.
 It is important for patients not to exceed the recommended dose of 10 mg daily (one tablet). Some patients have reportedly increased the dose of Hismanal in the belief that this would improve its efficacy or accelerate the onset of effectiveness.
 "While these rare cardiac events have been quite serious, patients can use Hismanal safely if they comply with the recommended dose," said FDA Commissioner David A. Kessler, M.D. "Patients with questions about the drug or its proper use should talk to their doctors."
 In some cases, patients have experienced fainting, dizziness and palpitations before their cardiac arrhythmias were recognized. Patients who faint while taking Hismanal should immediately discontinue use and consult their doctor for an evaluation, which may include electrocardiographic testing.
 Doctors and other health professionals will be notified of this information in a "Dear Doctor" letter. In addition, the package insert for Hismanal will now include a warning that patients with liver disorders should generally avoid use of the drug. Because the liver is extensively involved in metabolizing Hismanal, patients with liver disorders can accumulate excessive amounts of the drug, placing them at risk for cardiovascular events.
 The "Dear Doctor" letter includes the following boxed warning:
 "Rare cases of serious cardiovascular adverse events including death, cardiac arrest QT prolongation (a change in the EKG), torsades de pointes (a rare arrhythmia) and other ventricular arryhythmias have been observed in patients exceeding recommended doses of astemizole.
 "Do not exceed the recommended dose of 10mg (one tablet) daily."
 Hismanal (astemizole) is a nonsedating antihistamine prescribed for treatment of seasonal allergies and hives. A similar warning was recently issued for another nonsedating antihistamine drug, Seldane/Seldane-D (see P92-22, July 7, 1992). In the case of Seldane, however, the FDA particularly warned doctors about the interaction between Seldane and ketoconazole or erythromycin. No such drug interactions have been identified with Hismanal to date.
 The new warning will be included with other revisions in new labeling for doctors.
 FDA is one of the eight Public Health service agencies within HHS.
 -0- 7/20/92
 /NOTE: Attention TV broadcasters: Please use open caption for the hearing impaired./
 /CONTACT: Monica Revelle of the Food and Drug Administration, 301-443-4177, or after hours, 410-290-6575/ CO: Food and Drug Administration; Janssen Pharmaceutica ST: District of Columbia IN: MTC SU:


DC -- DC019 -- 0848 07/20/92 15:11 EDT
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Date:Jul 20, 1992
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