New Rules for Over-Counter Drugs Sought
The Food and Drug Administration on Thursday proposed new rules for cold medications that would allow over-the-counter sales of a prescription antihistamine and eliminate another compound that has been in use for 50 years because evidence shows it is of little value.
The agency also said that as part of a review of all non-prescription medications, researchers had determined that products that treat several symptoms of the common cold at once are “a convenience” to patients “who would otherwise have to take several products to treat congested and runny noses, watery eyes, headache and coughing.”
It proposed that 14 drug combinations should continue to be rated as “safe and effective.” Most of the major cough and cold combination products on the market would continue under this rating.
Products treating only single symptoms also would continue to be available, the agency said.
Non-Prescription Use
The FDA proposed that promethazine hydrochloride, an antihistamine now available only by prescription, be converted to non-prescription use in combination-ingredient cold products.
Another proposal calls for elimination of drug combinations that use theophylline. The agency said that while theophylline combinations have been used for years to ease labored breathing, research shows there is no convincing evidence that these combinations are of value.
The agency said the combination of theophylline and ephedrine has been in use for more than 50 years and the law did not require that their effectiveness be tested before they were first marketed. A 1962 law required such testing and the FDA is now reviewing all non-prescription ingredients.
If the proposed standard becomes final, some major products that use drug combinations that include theophylline would have to be reformulated or removed from the market. Among the products affected would be Primatene Tablets, Bronkotabs and Bronkolixir.
The proposed standard will be published today in the Federal Register, but would not become final until after an indefinite period allowed for public comment, the FDA said.
