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FDA Announces to Companies to Stop Marketing Products Containing Trimethobenzamide

Food and Drug Administration's (FDA) has announced that companies must stop manufacturing and distributing unapproved suppository drug products// containing trimethobenzamide hydrochloride. The declaration has come in the wake of on-going initiative to ensure that all marketed U.S. drugs have required marketing approval.

These products are used to treat nausea and vomiting in adults and children. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. These products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.

FDA urges consumers who are using suppositories containing trimethobenzamide, and who have questions or concerns, to contact their health care provider. There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today's action.

'FDA is continuing its work to remove unapproved drugs from the market,' said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). 'FDA is committed to ensuring that the medicines Americans rely on when they are sick are proven to be effective and safe.'

The Federal Register notice http://www.fda.gov/OHRMS/DOCKETS/ 98fr/78n-0224-nwl0002.pdf which outlines the agency's order to manufacturers and distributors, also concludes all outstanding issues for drugs containing trimethobenzamide, under the Drug Efficacy Study Implementation program (DESI). In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act to require that drugs be shown to be effective, as well as safe. Under DESI, FDA evaluated the evidence of effectiveness for thousands of drug products previously approved for safety only,
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