FDA Issues Warning on Cardiovascular Effects of Haloperidol
The FDA is warning clinicians about the risks for cardiovascular side effects and sudden death from haloperidol.
The agency says there are "at least 28 case reports" of QT prolongation and Torsades de Pointes in the literature associated with the antipsychotic drug, "especially when given intravenously"; some cases have been fatal. A 2005 postmarketing study conducted for the Italian drug authority, but only recently submitted to the FDA by Johnson & Johnson, found 13 additional cases. The FDA notes that the drug is often used intravenously off-label, especially in intensive care units, to treat severe agitation.
Label warnings will be strengthened, the FDA says, and it recommends ECG monitoring if the drug is used intravenously. The FDA urges particular caution in patients with other QT-prolonging conditions, such as electrolyte imbalance (especially hypokalemia and hypomagnesemia).
FDA alert (Free)
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