FDA Halts Sale of Suppositories with Trimethobenzamide

Drugmakers warned to stop manufacture and sale of suppositories containing the anti-nausea drug
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MONDAY, April 9 (HealthDay News) -- The U.S. Food and Drug Administration has warned drug manufacturers to stop making and marketing suppositories containing trimethobenzamide hydrochloride for nausea and vomiting. The suppositories have been sold under the names Tigan, Trimethobenz, Tebamide, T-Gen and Trimazide, but the FDA states that they are not approved and there is no proof that they work.

Under the FDA action, makers and distributors of trimethobenzamide-containing suppositories must halt interstate shipments of the suppositories by May 9. The order does not affect FDA-approved oral capsules and injection drugs containing trimethobenzamide.

"Prescription drugs that have not gone through the FDA approval process are of unproven safety and effectiveness," Deborah M. Autor, director of the Office of Compliance at the FDA Center for Drug Evaluation and Research, said in a statement. "Today's action helps ensure that health care providers prescribe, and consumers take, only medicines shown to be effective."

The FDA advised consumers who have been taking suppositories with trimethobenzamide to contact their physician.

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