Digestive Disorders Health Center
This article is from the WebMD News Archive
FDA Bans Some Rx Nausea Drugs
April 6, 2007 -- The FDA has ordered several brands of prescription nausea and vomiting medication off the U.S. market, saying the drugs had not received government approval.
Regulators said roughly a dozen manufacturers and distributors have until May 9 to cease sales of rectal suppositories containing the drug. The move does not affect several trimethobenzamide-containing oral drugs and injection drugs also used for nausea and vomiting.
About 2 million suppositories containing trimethobenzamide were sold last year, according to FDA.
The ban affects widely distributed brands including Tigan, Tegamide, Trimethobenz, and Trimazide.
Patients taking any of those brands should talk with their doctors, says Jason Woo, MD, associate director of scientific and medical affairs in the FDA’s Office of Compliance. Officials said they had no safety concerns but that manufacturers had not shown substantial evidence that trimethobenzamide is effective in suppository form.
“[Patients] should discuss the alternatives. There are approved suppository products that are on the market,” he says.
Trimethobenzamide is one of hundreds of drugs circulating in the U.S. despite never gaining FDA approval. A 1962 law forcing companies to prove a drug’s effectiveness before selling it exempted products on the market before that year.
The FDA first determined in 1979 that companies never proved trimethobenzamide suppositories are effective. But in June 2006, the agency began a crackdown on unapproved drugs.
Deborah M. Autor, director of the FDA’s Office of Compliance, acknowledged that trimethobenzamide has remained unhindered for a long time.
“I think there are probably several hundred unapproved prescription drugs out there,” Autor says. “We think it’s important to get the word out to the industry.”
Any company wishing to continue selling trimethobenzamide suppository after May 9 must go through the FDA’s full approval process, says Michael Levy, director of the agency’s New Drugs and Labeling Compliance division.
Those that don’t “will then be subject to immediate enforcement action such as seizure and injunction,” he says.
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Important Safety Information
- KAPIDEX may not be right for everyone. You should not take KAPIDEX if you are allergic to KAPIDEX or any of its ingredients. Severe allergic reactions have been reported.
- Symptom relief does not rule out other serious stomach conditions.
- The most common side effects of KAPIDEX were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). KAPIDEX and certain other medicines can affect each other. Before taking KAPIDEX, tell your doctor if you are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, or tacrolimus. If you are taking KAPIDEX with warfarin, you may need to be monitored because serious risks could occur.
Uses of KAPIDEX
- Persistent heartburn two or more days a week, despite treatment and diet changes, could be acid reflux disease (ARD). Prescription KAPIDEX capsules are used in adults to treat heartburn related to ARD, to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and to stop EE from coming back. Individual results may vary. Most damage (erosions) heals in 4–8 weeks.
Talk to your doctor or healthcare professional. Please see full Prescribing Information for KAPIDEX.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
KAPIDEX™ is a trademark of Takeda Pharmaceuticals North America, Inc., and is used under license by Takeda Pharmaceuticals America, Inc.
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