FDA Attempts to Restrict Cold- and Cough-Medications to Reduce Abuse among Adolescents
The U.S. Food and Drug Administration’s (FDA) Drug Safety and Risk Management Advisory Committee will meet on September 14, 2010 to discuss the increased prevalence of dextromethorphan abuse among the American public. After receiving a request from the Drug Enforcement Administration (DEA), the rising incidence of dextromethorphan abuse nationwide, especially among adolescents, has raised enough concern over the availability of cold- and cough-remedies containing this powerful drug that the Department of Health and Human Services (HHS) is now considering restricting the public’s access to these medications.
The abuse of dextromethorphan—a cough suppressant ingredient in more than 140 over-the-counter cold- and cough-medications—has nearly doubled among adolescents in the past few years. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), 12,584 emergency department visits involved DXM use in 2004, of which 5,581 visits were caused by nonmedical use of the substance. From these cases, 48% involved adolescents between the ages of 12 and 20. SAMHSA estimates that an average of 7.1 emergency department visits per 100,000 caused by the nonmedical use of DXM involve patients between 12 and 20 years of age. In comparison, the rate of DXM misuse among Americans of other age groups will cause an average of 2.6 emergency department visits per 100,000.
For that same year, the FDA estimates that 4,634 emergency department visits involved DXM overdose; by 2008, this figure had risen to 7,988 cases of overdose. In 2008, SAMHSA found that almost 1 million Americans between the ages of 12 to 25 had misused DXM that year: 30.5% had abused NyQuil, 18.1% had abused Coricidin, and 17.8% had abused Robitussin. Approximately 3.1 million Americans ages 12–25 have abused over-the-counter medications at some point during their lifetime. Over a third of DXM overdose cases among older adolescents also involve alcohol.
In light of these figures, the FDA’s Advisory Committee issued its first public warning regarding adolescents’ abuse of DXM, also known as "robo-tripping," by 2005. As of today, the incidences of DXM abuse and overdose have continued to escalate. In their upcoming meeting, the FDA will determine whether it should implement restrictions on the sale of over-the-counter medications containing DXM. The Advisory Committee will consider reclassifying DXM products as a controlled substance, making these medications available by prescription only. Most manufacturers of the over-the-counter medications disagree with this movement, suggesting that the restrictions will impede upon the public’s right to use DXM products, which when taken in regular dosages is quite safe. Some experts suggest restricting the sale of these products to minors to combat their misuse among adolescents, while still making them accessible to adults. Furthermore, parents should be better informed of DXM’s potential for abuse when they make their purchases.
The rate of DXM abuse among adolescents and young adults now greatly exceeds their rate of methamphetamine abuse. SAMHSA has found that adolescents who abuse DXM also have a high tendency to regularly abuse other substances, including marijuana (89.1%), hallucinogens like LSD, PCP, or ecstasy (44.2%), and inhalants (49.3%). When taken in large quantities that exceed normal dosage, DXM can produce euphoria, heightened awareness, dissociative experiences, and hallucinations, similar to PCP or ketamine abuse. When overdose occurs, DXM can cause severe adverse effects including loss of physical coordination, severe abdominal pain, nausea/vomiting, blurred vision, violent uncontrolled muscle spasms, delirium, heart arrhythmia, and death.
Source: Los Angeles Times, FDA weighs how to stop abuse of over-the-counter cough and cold drugs, August 31, 2010