F.D.A. Orders End to Production of a Form of Anti-Nausea Drug
By DONALD G. McNEIL Jr.
Published: April 7, 2007
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.
Hmm, that runs counter to my experience, especially in pediatrics. Interesting.