FDA issues notice to stop sale of unapproved nausea drugs

The US Food and Drug Administration (FDA) has asked drug companies to stop the manufacture of a number of anti-nausea drugs which contain trimethobenzamide stating that such drugs are not effective in stopping nausea and vomiting.
Posted : Sat, 07 Apr 2007 16:21:01 GMT
Author : Thomas Blythe
Category : Health
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The US Food and Drug Administration (FDA) has asked drug companies to stop the manufacture of a number of anti-nausea drugs which contain trimethobenzamide stating that such drugs are not effective in stopping nausea and vomiting.

Known popularly as "suppositories", the drugs were manufactured before 1962, after which any new drug had to be proven that it was effective. The drugs are sold in the market under brand names such as Tigan, Tebamide, T-Gen, Trimazide and Trimethoben. FDA said that the production of such drugs should be stopped since they were not approved by the agency.

In a notice sent to five companies that manufacture the drugs, FDA said, "Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness". The companies include Bio Pharm Inc., Dispensing Solutions Inc., G & W Laboratories Inc., Paddock Laboratories Inc. and Perrigo Co.

FDA also asked consumers of such drugs to consult with their doctors to find alternative remedies for their ailments. "There are many alternative products approved to effectively treat nausea and vomiting, and that are available in a variety of forms, including tablets, capsules, solutions, injectables and suppositories", it said in a statement.

However FDA said that oral preparations as well as injectible products could still be sold.

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