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