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    Medication Event Alert April 9, 2007
The following was excerpted from an FDA Med Watch alert dated April 6, 2007: "FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting in adults and children. The products have been marketed under various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness. This action does not affect oral capsules and injectable products containing trimethobenzamide that have been approved by FDA. FDA urges consumers currently using trimethobenzamide suppositories or who have questions or concerns to contact their healthcare professional. Alternative products approved to effectively treat nausea and vomiting are available in a variety of forms. Several oral capsules and injectable products containing trimethobenzamide have been approved by FDA and are not affected by today's action. The Federal Register notice 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, including those products marketed under the name of Tigan containing trimethobenzamide. Because DESI findings apply to any unapproved products that are identical, related, or similar to DESI-reviewed drugs, today's notice makes the marketing of any unapproved trimethobenzamide hydrochloride suppository products unlawful. Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007. A small amount of these products will still be available in pharmacies after that date until supplies are exhausted. Any company wishing to market a product containing trimethobenzamide in suppository form must now obtain an approved new drug application prior to marketing. For additional information regarding FDA's Unapproved Drugs Initiative visit http://www.fda.gov/cder/drug/unapproved_drugs." |
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