Janssen, United States of America. Janssen, the manufacturer of the histamine H1-receptor antagonist, astemizole, (Hismanal) has announced that it is voluntarily withdrawing the 10-mg formulation from the market.
Since the drug’s approval in 1988, new adverse reaction data has necessitated a series of labelling changes and warnings. In the light of the choices of other prescription antihistamines now available and the overall risk benefit profile of this drug, the Food and Drug Administration supports the decision of the company to withdraw the product.
Patients who have been taking astemizole for allergy symptoms should consult their doctors to determine an appropriate alternative treatment.
[See also Pharmaceuticals Newsletter Nos. 3&4, March&April 1998]
Reference: FDA Talk Paper T99-29 dated 21 June 1999.