Does It Work? Not This Drug, Says the FDA
The Food and Drug Administration has banned antinausea suppositories that contain a particular ingredient because evidence is inadequate to show that the suppositories actually work. The ingredient, trimethobenzamide hydrochloride, is among hundreds of substances used in thousands of prescription drugs that long ago were approved for safety but never for effectiveness. Many physicians and pharmacists don't know that, and the labels don't indicate it.
The suppositories pulled off the shelves were sold as Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Possible substitutes include capsules and injectable forms of trimethobenzamide and suppositories formulated instead with promethazine.
The ban is part of an ongoing effort to tackle such unapproved drugs, which the FDA says make up about 2 percent of all prescription drugs. Most of them were on the market before 1962, when Congress changed the law to add effectiveness to the previous safety requirement but permitted doctors to prescribe and pharmacists to sell drugs that already were on the market. The FDA's review of all 3,400 of those previously approved drugs has been grinding away for the four-plus decades since then.
The FDA had concluded by 1979 that the trimethobenzamide-based suppositories were ineffective. But they continued to be sold–beneficiaries of the agency's lack of resources and a bureaucratic regulatory process. The FDA has new resolve, vows Deborah Autor, director of the FDA Center for Drug Evaluation and Research's office of compliance. "This is an issue the FDA is making a concerted effort to tackle," she says. "We're making every effort to get this problem wrapped up."
Anyone can determine whether a particular prescription medication has been approved for both safety and effectiveness by going to Drugs@FDA and typing in the drug's active ingredients. If the approval does not appear, a pharmacist or the manufacturer might be able to provide information.
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