Non-FDA-Approved Anti-nausea Suppositories

Companies have been ordered to stop manufacturing and distributing suppositories containing trimethobenzamide HCl because they lack effectiveness. Used to treat nausea and vomiting in adults and children, they have not been FDA-approved.

The affected products include Tigan (King), Tebamide, T-Gen, Trimazide, and Trimethobenz. Several oral capsules and injectable products containing trimethobenzamide have been approved by the FDA and are not affected by this action.

The move was part of a campaign by the agency to re-evaluate drugs approved before 1962, the year drug makers had to start proving that their products worked. Before 1962, they had to prove only that they caused no harm.

Many alternative products are available as tablets, capsules, solutions, inject-ables, and suppositories. canadian antibiotics

A small quantity of these products will still be available in pharmacies until supplies are exhausted. Five manufacturers and six distributors make these suppositories. Drug companies wishing to market a trimethobenzamide product in suppository form must now obtain an approved New Drug Application prior to marketing.