June 21, 1999
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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
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