ABSTRACT
On February 9, 1998, the FDA advised health professionals regarding new warnings in the labeling of astemizole, an oral antihistamine. The FDA talk paper can be found at the following Internet address: https://www.fda.gov/bbs/ topics/ANSWERS/ANS00848.html
Per the manufacturer’s Dear Doctor Letter (February 1998), astemizole use is contraindicated in patients with severe hepatic dysfunction or with concur rent therapy known to impair the drug’s metabolism such as clarithromycin, troleandomycin or mibefradil. This is in addition to previously contraindicated drugs (i.e., ketoconazole, itraconazole, erythromycin and quinine). QT interval prolongation and cases of severe cardiovascular events have been reported.
