FRIDAY, April 6, 2007 (HealthDay News) -- Almost 30 years after discovering no value to a suppository drug used to treat nausea and vomiting, U.S. officials on Friday ordered manufacturers to stop selling the product.
The unapproved product, which contains trimethobenzamide hydrochloride, is sold under such names as Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.
"Any company wishing to market a product containing trimethobenzamide in suppository form must obtain an approved new drug application," Michael Levy, director of the U.S. Food and Drug Administration's Division of New Drugs and Labeling Compliance, said during a teleconference.
In 1979, the FDA first determined there was no benefit to be gained from these products, which are typically prescribed for patients with the flu and other illnesses and are usually taken three or four times a day. It has taken since then -- and a recently renewed effort to ban unapproved prescription drugs -- to reach Friday's decision.
There were many reasons for the delay, Levy said. They included gathering all the evidence on the drug's effectiveness and handling a request for a new review by the manufacturer of Tigan, Levy added.
The FDA said several oral capsules and injectable products containing trimethobenzamide are approved and aren't included in the ban.
"Companies manufacturing or marketing trimethobenzamide hydrochloride suppository products must cease shipping them in interstate commerce by May 9, 2007," Levy said. Companies that don't adhere to the ruling will be subject to enforcement action, including seizure and injunctions, he said.
There are five manufactures and six distributors of these suppository products, Levy said. An estimated 2 million of these suppositories are used each year in the United States. A list of the suppository makers would be made available later Friday, he added.
The FDA is asking people who are using the suppositories, and those who have questions or concerns, to contact their doctor.
There are many other products approved to treat nausea and vomiting, Levy said, adding that these products are available in several forms, including tablets, capsules, solutions, injectables and suppositories.
Prescription drugs that aren't approved by the FDA "may not be safe, effective or adequately labeled, and they may be substandard," Levy said. "These products present a significant safety risk."
"Last June, we announced a new emphasis tackling unapproved drugs," Deborah M. Autor, director of FDA's Office of Compliance, Center for Drug Evaluation and Research, said during the teleconference.
More information
For more information on trimethobenzamide, visit the U.S. National Library of Medicine.
