Zoloft with pimozide contraindicated

OB/GYN News, Feb 1, 2003 by Deeanna Franklin

At the request of the U.S. Food and Drug Administration, Pfizer has issued a warning on possible interaction between its drug sertraline (Zoloft) and the antipsychoric drug pimozide (Orap).

Pimozide is indicated for the suppression of severe motor and vocal tics due to Tourette's syndrome, only after the failure of other treatments. It is manufactured by Gate Pharmaceuticals.

Pfizer's letter to health care professionals informs them of a change in the prescribing information for sertraline tablets and oral concentrate. Under the contraindications section, it now states "concomitant use [of sertraline] in patients taking pimozide is contraindicated."

The interaction between pimozide and sertraline was brought to light in the "Phase 1 Open Study Designed to Determine the Potential Interaction of Sertra line With Cisapride or Pimozide in Healthy Male and Female Subjects." In this controlled study, a standard 2-mg dose of pimozide was administered to participants already receiving 200 mg daily of sertraline. When combined in this way, absorption of pimozide increased by an average of 40%.

Despite the increased absorption, the study found no changes in heart function as measured by electrocardiogram. However, since the highest recommended dose of pimozide is 10 mg, and at this dosing it has not been studied in combination with sertraline, the effect on heart function at doses over 2 mg are unknown.

Copies of the letter can be viewed at the Food and Drug Administration's MedWatch Web site, www.fda.gov/medwatch/safety/2002/zoloft.htm.>

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