Anti-Nausea Drug Production Stopped by F.D.A.

The Food and Drug Administration yesterday ordered drug companies to stop making and selling anti-nausea suppositories containing a drug that the agency said did not work when used in that form.

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 did no harm.

The suppositories, sold by prescription under the names Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz, all contain the active ingredient trimethobenzamide.

About two million such suppositories are sold each year, said Dr. Jason Woo, an official in the agency’s compliance office.

Trimethobenzamide in other forms, including pills and injectables, does have F.D.A. approval for use against nausea and vomiting, the agency said.

The agency has had evidence since 1979 that trimethobenzamide suppositories do not work. But the review “requires a lengthy analysis,” Dr. Woo said. Also, the drug makers requested a hearing, “which further slowed the process,” he said.

Last June, the agency began “reinvigorating” the process, said Deborah M. Autor, the compliance office’s director.

Since then, it has removed its previous approvals of products containing quinine for leg cramps, ergotamine tartrate for migraines and carbinoxamine for children’s allergies and colds.

Although the agency estimates that less than 2 percent of prescription drugs sold now are unapproved, it believes there are “several hundred” unapproved active ingredients in prescription drugs.

Representatives of the companies making the suppositories could not be reached yesterday because of the holiday. The companies have until May 9 to comply with the F.D.A. order.