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T99-29
June 21, 1999

Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA

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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