FDA Regulators Weigh Cough Syrup Crackdown

A steady increase in the prevalence of OTC drug abuse by teens has caused the FDA to reconsider its position on dextromethorphan.

Prompted by a surge in abuse by adolescents, an FDA advisory committee is considering scheduling the cough suppressant dextromethorphan (DXM) as a controlled substance. If enacted, the regulation would severely limit the availability of more than 100 OTC cough and cold medicines that list DXM as an active ingredient.

In a meeting scheduled for September 14, the committee will use findings from a 135-page FDA report, issued Tuesday, to determine whether DXM’s potential for abuse warrants further restrictions.

The decision to review the scheduling of DXM followed a request by the Drug Enforcement Agency (DEA), which reported a more than threefold increase in the number of emergency room visits linked to nonmedical use of DXM between 2002 and 2008.

Known as “robo-tripping,” “tussing,” or “skittling,” recreational use of DXM induces euphoric effects, including heightened sensory awareness, altered time perception, and visual and auditory hallucinations. Teenagers are more likely than others to abuse the drug, often taking doses 25 to 50 times greater than the recommended amount.

Because DXM is commonly combined with acetaminophen, pseudoephedrine, and antihistamines, high doses of DXM-containing medicines can result in liver damage, increased blood pressure, and other adverse effects. Combining it with alcohol or other drugs is especially dangerous, and has resulted in deaths, according to the DEA.

Critics of scheduling the drug claim it will prevent responsible use of common OTC medicines, punishing patients with no intent to abuse. Elizabeth Fuderburk, a spokesperson for the Consumer Healthcare Products Association (CHPA), told Bloomberg in an email, “Our goal is to stop the intentional abuse of cough medicine while allowing for continued, responsible availability of these medicines.”

To that end, CHPA has launched several online initiatives to raise awareness about DXM abuse, and collaborates with the Partnership for a Drug-Free America, the Community Anti-Drug Coalitions of America, and D.A.R.E. America, among other groups.

Despite these efforts, the organization’s Web site, www.chpa-info.org, was panned by a panel of FDA reviewers, who argued it was fragmented and failed to target those most at risk—“tweens,” teens, and young adults. Here, a video clearly designed for parents and educators appears to confirm the FDA’s assessment:

Labeling changes or warnings on the packaging of OTC medicines are also unlikely to curb abuse, according to the FDA. “Because of the drug’s perceived safety, ease of availability, and desired psychoactive effects, it is sought after by those seeking to alter their mental state,” the report stated. “Therefore, routine labeling changes or product packaging redesign will probably not reduce the present abuse trend.”

For other articles in this issue, see:

• Pharmacy Times Mobilizes With New iPad App
• Dark Chocolate Lowers Heart Failure Risk
• HHS Widget Links Patients to Affordable Coverage