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New Hismanal Labelling Warns Of Drug Interaction Complications WASHINGTON, MD -- February 10, 1998 -- The United States Food and Drug Administration (FDA) is warning consumers and health care providers about new safety information regarding Janssen Pharmaceutica’s prescription antihistamine Hismanal (astemizole) and its potential effects when combined with other drugs. 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. According to the FDA, Hismanal is associated with life-threatening irregular heart rhythms when taken with certain other drugs and when used at higher than the recommended dose. The new labelling will include a specific warning against combining Hismanal with certain drugs such as the hypertension drug, Posicor (mibefradil dihydrochloride) and the antibiotics, Biaxin (clarithromycin) and TAO (troleandomycin). The new labelling also warns against using Hismanal with a number of other drugs, including: 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. Research has shown that grapefruit juice can interfere with the body's handling and metabolism of Hismanal. The new labelling also warns against prescribing Hismanal in patients with liver disorders. More information on: Hismanal, Janssen Pharmaceutica E-mail this page to a friend or colleague! To print, use this version