U.S. moves to stop sale of some nausea drugs
WASHINGTON (Reuters) - Companies must stop selling suppositories that contain trimethobenzamide to relieve nausea and vomiting because they have not been proven effective, U.S. health officials said on Friday.
The prescription-only suppositories have been sold for children and adults under names including Tigan, Tebamide, T-Gen, Trimazide and Trimethobenz but are not approved, the Food and Drug Administration said.
"Drugs containing trimethobenzamide in suppository form lack evidence of effectiveness," a notice from the Food and Drug Administration said.
About 2 million of the suppositories are prescribed each year, FDA officials said.
The agency identified five companies that manufacture trimethobenzamide suppositories. The FDA said the makers were Bio Pharm Inc., Dispensing Solutions Inc., G & W Laboratories Inc., Paddock Laboratories Inc. and Perrigo Co.
Dispensing Solutions does not manufacture the products but was a distributor, said Richard Wolpow, one the company's owners. The company stopped distributing the suppositories after the FDA issued its notice, he said.
Allan Slizewski, vice president for sales and marketing at Paddock Laboratories, said "when we hear from the FDA, we will comply with them."
Officials at the other makers could not immediately be reached for comment.
The FDA also listed seven companies including Bio Pharm as distributors of the products.
FDA officials urged consumers using the suppository form of trimethobenzamide to discuss other options with a doctor.
"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," the agency said.
Oral capsules and injectable products made with trimethobenzamide can still be sold, the FDA said.
Companies must stop shipping suppositories with the ingredient by May 9. Any company that wants to keep selling the products must file an application and get FDA approval.
The FDA move is part of an effort to force unapproved medicines from the market.
