Final Rule Issued on OTC Cough Medicines
FDA has decided not to allow a prescription cough-suppressant drug to be sold over the counter because, if used improperly, it could cause severe reactions such as choking.
The decision is part of the agency's final rule on over-the-counter antitussives (cough relief products). The rule, published in the Aug. 12 Federal Register, lists the ingredients that FDA considers safe and effective.
In the rule, the agency explained that the drug benzonatate has been marketed as a prescription drug for 24 years with few adverse reactions. Because of that safe record, the agency proposed in 1983 to allow it to be sold over the counter. However, if benzonatate is chewed or allowed to dissolve in the mouth instead of being immediately swallowed, it can cause numbness and possible paralysis of the mouth and throat. At the time FDA proposed the change, it considered that a warning label would be sufficient to protect consumers. Comments received in response to the proposal, however, convinced the agency that benzonatate should remain a prescription drug, to be used only under professional supervision.
Other provisions in the final rule include:
A dispensing device calibrated for age and weight must be included with codeine-containing products intended for children between the ages of 2 and 6.
Camphor and menthol may be used in hot steam vaporizers and in ointments rubbed on the chest. When sold for inhalation, these ingredients must include the warning statement, "For steam inhalation only. Do not take by mouth.'
The prescription cough suppressant chlophedianol hydrochloride will change to OTC status.
The OTC drugs dextromethorphan, dextromethorphan hydrobromide, camphor, menthol, codeine, codeine phosphate, and codeine sulfate have been determined safe and effective cough suppressants that may continue to be marketed over the counter. (In many states, however, codeine is a prescription drug.)
Under the final rule, any other cough-suppressant ingredients intended for over-the-counter use will require FDA approval before they can be marketed.
COPYRIGHT 1987 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group
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