FDA Bans Some Suppository Drugs Used to Treat Nausea, Vomiting

The FDA has ordered a halt to all manufacturing and distribution of unapproved suppository drugs containing trimethobenzamide hydrochloride.

According to the FDA, "drugs containing trimethobenzamide in suppository form lack evidence of effectiveness." The suppositories have been sold under various brand names, including Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz. The drugs, which are used to treat nausea and vomiting in both adults and children, may not be shipped after May 9. Companies wanting to market suppository products that contain trimethobenzamide must submit a new drug application for approval from the FDA.

The decision was made under the Drug Efficacy Study Implementation, or DESI, program, a 1962 amendment to the Federal Food, Drug and Cosmetic Act that required that drugs be shown to be effective as well as safe. Using the DESI, the FDA evaluated thousands of drug products previously approved only on the basis of being safe to use. One of those products was Tigan, which later failed to pass efficacy tests. DESI findings apply to all unapproved products "identical, related or similar" to the DESI-tested drug, so all unapproved trimethobenzamide hydrochloride suppositories have been pulled from the market.

Several oral capsules and injectable products containing trimethobenzamide have been approved by the FDA. Those products are not affected by this order. In addition, the FDA says that numerous alternative products in various formulations have been approved to treat nausea and vomiting and are available on the market. Patients are encouraged to contact their physicians or other health professionals with questions about the FDA action.