FDA to discuss concerns over medicines with DXM

SILVER SPRING, Md. The Food and Drug Administration last week issued an information packet in preparation for a Sept. 14 advisory committee meeting that will address the potential abuse of dextromethorphan products and whether restrictions should be placed on the sale of those over-the-counter cough medicines.

Members of both the FDA Drug Safety and Risk Management Advisory Committee and the FDA Nonprescription Drugs Advisory Committee will be in attendance at the public meeting.

Included in the 135-page packet is a Drug Enforcement Agency summary of that agency’s concerns over the abuse potential of DXM, a list of substances included as part of the Controlled Substances Act, the approval history and OTC monograph of DXM, abuse-related pharmacology reports, a clinical perspective in the treatment of cough, drug utilization data, Drug Abuse Warning Network data, adverse event reports and a review of the Consumer Healthcare Products Association’s website designed to raise awareness among parents and school authorities around the abuse of nonprescription medicines. According to the docket, the CHPA actively has engaged parents and other groups around effective methods in preventing abuse of OTCs and other medicines since May 2006.

“CHPA does not believe scheduling of dextromethorphan under the Controlled Substances Act is warranted,” the association stated in a 93-page briefing book available to meeting attendees. “The prevalence and scope of reported abuse is limited. CHPA believes that there are more effective interventions to address OTC cough medicine abuse in general, and dextromethorphan abuse in particular, that preserve the significant public health benefit of consumer OTC access to these important cough medicines.”

The abuse of DXM products has been the focus of two previous FDA advisory committees. In August 1990, an advisory committee was convened as a result of reports of abuse of DXM containing cough syrups by teenagers in areas of Pennsylvania and Utah. The committee was asked to help the FDA develop a strategy for assessing the problem and discuss possible solutions. The committee recommended that the sponsor provide additional data on the toxicity of the substance in the higher dose range, and that additional epidemiological data be gathered so that the FDA could better assess the scope and significance of abuse, and the risk to the public health.

In July 1992, the committee reconvened and discussed several proposed epidemiological studies on DXM abuse, including conducting a national survey from interviews with drug-free school coordinators, and evaluating attitudes and behaviors of potential and actual DXM abusers and how they might be affected by an abuse prevention program.

“Although no clear consensus on the extent of the problem or solutions came out of this meeting, there was a general recognition, in this early pre-Internet era, that outbreaks of abuse occurred in small communities, that the DXM abuse problem had not risen yet to the national level and further studies should focus on areas where abuse outbreaks are occurring,” the report, issued by Michael Klein, director of the FDA’s controlled substance staff, read.