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
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.