COLLEGE PARK, Md. – A Food and Drug Administration panel on Sept. 14 voted 15 to 9 against requiring that the cough suppressant dextromethorphan be scheduled under the Controlled Substances Act.
The drug is used in more than 100 over-the-counter cough and cold products available in a wide range of retail outlets. Those voting against scheduling cited concerns about limiting access to the drug, which can be effective for coughs.
The panel was asked to consider the need to schedule dextromethorphan based on a request from the Drug Enforcement Administration for a scientific and medical evaluation and scheduling recommendation. Dextromethorphan abuse has been an ongoing concern for both the FDA and the DEA, starting in the early 1990s. The dextromethrophan-related deaths of five teenagers from the states of Washington, Florida, and Virginia brought the problem to back to national attention in 2005. In each case, death was determined to be the direct result of the toxic effects of dextromethorphan powder. Other case reports of abuse and the effects of overdose of products containing dextromethorphan have been reported in the literature.
The panel also was tasked with determining if the scientific data supports abuse potential for dextromethorphan. In general, panelists agreed that dextromethorphan has abuse potential, but its abuse potential relative to other abused substances is unclear. In 2008, dextromethorphan accounted for almost 8,000 emergency department visits due to nonmedical use (taken as a cough suppressant, alone, or in combination with other medications), based on data from the Drug Abuse Warning Network. That number is up from more than 4,600 in 2004.
The FDA also asked the panel to discuss the effectiveness of current and planned abuse mitigation strategies and to recommend modifications or other measures. Access to bulk dextromethorphan – often used to make capsules used recreationally and available online – was also a significant concern for the panel.
The 2005 deaths prompted the FDA to publish a Talk Paper to warn the public about the risks associated with abuse of the drug later that year. Starting in May 2006, the Consumer Healthcare Products Association – which represents several makers of OTC dextromethorphan–containing products – began to develop voluntary initiatives to reduce teen abuse of dextromethorphan. More information is available at www.stopmedicineabuse.org.