[U.S. Food and
Drug  Administration]

Disclaimer FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from Janssen Pharmaceutica. Contact the company for a copy of any referenced enclosures.


June 18, 1999

Dear Health Care Professional:

Janssen Pharmaceutica would like to inform you that we have decided to voluntarily discontinue the manufacturing, distribution and marketing of HISMANAL® (astemizole) 10 mg Tablets. We have informed the U.S. Food and Drug Administration. HISMANAL is an antihistamine indicated for relief of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria. The company is taking this action after careful consideration of the antihistamine class, which includes multiple alternative medications.

Physicians who currently have patients taking HISMANAL should consider future alternative treatment. Pharmacists who receive prescriptions for patients taking HISMANAL should contact the prescriber to discuss alternative treatment.

Please see full Prescribing Information enclosed including Box Warning. If you or your patients require additional medical information, please contact our Health Care Professionals at Janssen One to One™ Customer Action Center at 1-800-JANSSEN (526-7736) 8:00 A.M. to 8:00 P.M. Eastern Time, Monday through Friday.

Sincerely,

Jan Gheuens, M.D.
Vice President, Medical Affairs
Janssen Pharmaceutica

JPI-HS-286


Janssen at Washington Crossing
1125 Trenton-Harbourton Road
Post Office Box 200
Titusville, New Jersey 08560-0200


Return to Summary


Return to MedWatch
Home Page Your Comments Please Return to Safety Issues Page

MedWatch

[FDA Home Page]