E-DRUG: U.S. FDA issues Warning on Astemizole

[srahmad@essential.org]

E-DRUG: U.S. FDA issues warning on the antihistamine astemizole
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T98-5                       Ivy Fleischer Kupec:  301-827-6242
Feb. 9, 1998                Broadcast Media:      301-827-3434
                            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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