USA. Pfizer Inc, under advice from USFDA is informing healthcare professionals about a change in the prescribing information for sertraline hydrochloride (Zoloft) tablets and oral concentrate. This advice was issued after a study showed that concomitant administration of sertraline hydochloride (Zoloft, 200 mg) in patients given a single dose of pimozide (2 mg) increased the plasma concentration of pimozide by about 40%. The mechanism of this interaction remains unknown. According to Pfizer, given the narrow therapeutic index of pimozide and the fact that the interaction occurred with a low dose of pimozide, concomitant administration of sertraline (Zoloft) and pimozide should be contraindicated. The Contraindications and Precautions sections for sertraline have been appropriately modified to reflect this new information. Sertraline (Zoloft) is indicated for the treatment of major depressive disorder, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder and premenstrual dysphoric disorder and pimozide in the treatment of Tourette’s syndrome.
Letter from Pfizer Inc, Nov 2002. Available from URL: http://www.fda.gov