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. 

T98-5                       Ivy Fleischer Kupec:  301-827-6242
Feb. 9, 1998                
                            Consumer Inquiries:   800-532-4440

IMPORTANT NEW SAFETY INFORMATION ABOUT HISMANAL

FDA today is warning consumers and health care providers about new safety information regarding the prescription antihistamine Hismanal (astemizole). This warning is being issued in conjunction with the addition of more information in the product label about cardiovascular adverse events, new potentially serious drug interactions and rare reports of anaphylaxis, a potentially life-threatening reaction. The following can be used to answer questions:

Hismanal is associated with risks of death due to irregular heart rhythms when taken with certain other drugs and when used at higher than the recommended labeled dose. The new labeling provides information about a specific warning against simultaneously using Hismanal with other types of drugs such as the hypertension drug, Posicor (mibefradil dihydrochloride), and the antibiotics, Biaxin (clarithromycin) and TAO (troleandomycin).

The new labeling also provides additional precautions against using Hismanal with a number of other drugs. These include: HIV protease inhibitors such as Crixivan (indinavir), Norvir (ritonavir), Invirase (saquinavir) and Viracept (elfinavir); serotonin reuptake inhibitors such as Prozac (fluoxetine), Luvox (fluvoxamine), Zoloft (sertraline), Serzone (nefazodone) and Paxil (paroxetine); and the antiasthma medication Zyflo (zileuton). Additionally, the label now recommends that Hismanal should not be taken with grapefruit juice. These recommendations are based on the potential of these drugs and grapefruit juice to interfere with the body's handling and metabolism of Hismanal.

The new labeling also emphasizes that patients with liver disorders should not take Hismanal.

The new labeling is designed to give health care providers and consumers who use Hismanal the latest available information about these risks.

In the event of Hismanal-related adverse events, health care providers are urged to contact the manufacturer, Janssen Pharmaceuticals One-to-One Customer Action Center at 1-800-JANSSEN (526-7736) or FDA MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-1078 or (mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.

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