FDA Panel Votes Against Restricting Dextromethorphan Sales

An FDA advisory panel decided not to schedule the cough syrup ingredient dextromethorphan (DXM) as a controlled substance, following a 15 to 9 vote against the proposal on Tuesday.

Siding with the Consumer Healthcare Products Association (CHPA) and the National Association of Chain Drug Stores (NACDS), the committee determined that controlling DXM would unduly restrict access to hundreds of OTC medicines that contain the cough-suppressing ingredient.

The Drug Enforcement Administration asked the FDA to reconsider its stance on the sale of medicines containing DXM due to an increase in abuse by adolescents. Records held by the DEA show that emergency department visits related to DXM abuse have risen sharply in recent years, from 4634 cases in 2004 to 7988 cases in 2008.

Kevin Nicholson, RPh, vice president of regulatory affairs at NACDS, attended the September 14 meeting to deliver testimony on DXM’s risks and benefits. “Depriving consumers of the option to self-medicate with dextromethorphan would have substantial public health consequences,” Nicholson warned. He argued scheduling the drug as a controlled substance would also substantially increase health care costs, forcing patients to visit physicians for routine treatment of cough and cold.

To address the problem of abuse, Nicholson urged the FDA to instead consider prohibiting the sale of DXM to minors—a solution proposed by Senator Dick Durbin (D, IL) in the Dextromethorphan Abuse Reduction Act of 2009. A statement issued by CHPA said an age limit would curb abuse by adolescents, but that any legislative action should be supported by broad research-based education initiatives.

“Research over the past 35 years clearly shows that targeted educational interventions focusing on increased parental awareness and increased perceptions of the risks and social disapproval are the most effective abuse-reduction strategies,” the statement read.