FDA orders nausea suppository off the market

The makers of about two million suppositories sold each year for nausea and vomiting must stop selling the prescription drugs because evidence does not show they work, regulators said yesterday.

The decision follows a 2005 letter from King Pharmaceuticals Inc., based in Bristol, Tenn., saying it would not pursue studies to prove the effectiveness of its version, called Tigan, according to the Food and Drug Administration. Forms of the drug other than the suppositories, which are inserted into the rectum, can continue to be sold, the FDA said in a statement.

The agency said patients could use alternative forms of the drug, trimethobenzamide, marketed as capsules or injections by makers including King and Icelandic generic-drug maker Actavis Group hf. The agency is reviewing drugs that were sold with safety approval before Congress required effectiveness testing in 1962 and that continued to be marketed later without meeting the new standards.

"The FDA expects all marketed products to have approval," Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, said in a conference call with reporters. "Unapproved drugs have not been through the rigorous application process."

Five manufacturers and six distributors make the suppositories, Levy said. King bought the rights to Tigan suppositories, capsules and injections in 1999 from Roberts Pharmaceutical Corp., the FDA said in a Federal Register notice on its Web site.

King is listed on the agency's Web site as having approval for Tigan oral capsules and injections. Voice-mail messages for James Green and David Robinson, spokesmen for King, weren't immediately returned.

Companies marketing the suppositories must stop shipping them by May 9, Levy said. Some products will be available in pharmacies after that date until supplies are exhausted. People currently using the drugs should contact their health-care providers with concerns or questions, the agency said.