FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857


FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T99-29                     Print Media:         301-827-6242
June 21, 1999              
                           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 drugís 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.

####


Link to FDA HOME PAGE