E-DRUG: Alert: Allergy drug astemizole withdrawn in the U.S.
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[Editorial note: Astemizole is a drug similar to terfenadine. Both of
these drugs were associated with serious life threatening cardiac
adverse events including deaths, arrhythmias, QT prolongation, and
torsades de pointes. Terfenadine was withdrawn from the U.S. market in
January 1997 and today the manufacturer has announced the withdrawal of
astemizole. U.S. FDA's Talk Paper and the manufacturer's Dear Health
Care Professional letter is reproduced below. Syed Rizwanuddin Ahmad]
June 21, 1999
JANSSEN PHARMACEUTICA ANNOUNCES THE WITHDRAWAL OF HISMANAL FROM THE
MARKET
Janssen Pharmaceutica, Inc., of Titusville, N.J., has announced that it
is voluntarily withdrawing the prescription antihistamine, Hismanal
(astemizole) 10 mg., from the market.
Since the drug's approval in 1988, new adverse reaction data has
required a series of labeling changes and warnings. In light of the
choices of other prescription antihistamines now available, and the
overall risk benefit profile of this drug, FDA supports the decision of
the company to withdraw the product.
Patients who have been taking Hismanal for their allergy symptoms should
consult with their doctors to determine an appropriate alternative
treatment.
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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
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