Magazine article Clinical Psychiatry News

Ziprasidone Label Clarifies Contraindicated Drugs. (Manufacturer Cites Misinterpretations)

Magazine article Clinical Psychiatry News

Ziprasidone Label Clarifies Contraindicated Drugs. (Manufacturer Cites Misinterpretations)

Article excerpt

The list of drugs that are contraindicated with the atypical antipsychotic drug ziprasidone because they prolong the QT interval of electrocardiograms has been expanded in the drug's labeling.

The contraindications section in the previous label stated that ziprasidone should not be used with other drugs that prolong the QT interval because of "ziprasidone's dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs." The section included a list of seven drugs the label called incomplete.

The revision does not reflect new information or postmarketing safety reports. It is intended to "clarify" information already included in the drug's labeling, according to a letter issued last month by ziprasidone's manufacturer, Pfizer Laboratories. Ziprasidone, marketed as Geodon, was approved for treating schizophrenia in February 2001.

But the Pfizer letter notes that "not all physicians, pharmacists, and pharmacy databases interpreted this language as intended," and as a result, some may have considered certain drugs as not contraindicated, while others believed that all drugs associated with QT prolongation were contraindicated with ziprasidone. Thus Pfizer and the Food and Drug Administration agreed that the issue needed to be clarified.

Previously, the seven drugs listed were dofetilide, sotalol, quinidine, thioridazine, moxifloxacin, pimozide, and sparfloxacm. The additions are "other class Ia and III antiarrhythmics," mesoridazine, chlorpromazine, droperidol, gatifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, and tacrolimus.

In June 1998, the FDA issued a nonapprovable letter for ziprasidone because of concerns over prolongation of the QTc interval, which can lead to the potentially fatal arrhythmia, torsades de pointes. …

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