FDA Calls for Boxed Warning on Gastrointestinal Drug

28 feb 2009--All metoclopramide-containing products must carry a boxed warning on the risk for tardive dyskinesia, the FDA announced on Thursday. (The products' labels currently include a less severe warning on the condition.)

Metoclopramide, used to speed gastric emptying and as an anti-emetic, may put patients at risk when used chronically or in high doses, and treatment beyond 3 months is not recommended. According to the FDA, chronic use "should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

Older individuals, especially women, appear to be at highest risk.

Affected products include metoclopramide oral solution and Reglan sold in tablet, oral disintegrating tablet, and injectable form.

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