Over-the-Counter Cough Medicines Escape FDA Restrictions
Regulators scrutinized the over-the-counter drugs in light of abuse by teens.
Sept. 14, 2010— -- Doctors, schools and law enforcement have been concerned about young people abusing the active ingredient in many over-the-counter cough remedies -- but the medicines will likely remain available without a prescription.
A U.S. Food and Drug Administration advisory panel voted today against requiring prescriptions for dextromethorphan (DXM), which was responsible for an estimated 7,988 emergency department visits in 2008, up from 4,634 in 2004, according to FDA documents. The panel opposed regulating it under the Controlled Substances Act.
The FDA usually follows advisory panel suggestions, but is not bound by them. Congress still could move to limit sales to anyone under the age of 18.
The Consumer Healthcare Products Association, which represents over-the-counter drug makers, applauded the panel's decision.
"Today's FDA advisory committee decision not to recommend scheduling OTC cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan," the group said in a statement.
"We do, however, recognize the need for continued education to keep any abuse levels low."
More than 120 cough preparations contain DXM, which received FDA approval in 1958 as a non-addictive replacement for codeine and has undergone multiple safety reviews. Considered safe and effective at recommended doses with minimal adverse effects, DXM has become the most widely used cough suppressant in the United States.
Among the best-known brands containing DXM is Robitussin. Some teens and tweens have told of going "Robo tripping," swallowing large doses of Robitussin in search of a cheap high.
Other nicknames for DXM-containing pills, tablets, gel capsules or powders include "robo," "tussin," "dex," "rojo" and "red velvet." Coricidin HBP Cough & Cold, sometimes called "Triple C" for the three C's imprinted on the red tablets, contains some of the highest DXM doses of any non-prescription cough product.
DXM doesn't make for a very pretty high. At recommended doses of up to 30 milligrams for coughs, it can produce nausea, digestive disturbances, drowsiness and dizziness. At doses of 250 to 1,500 mg, typically taken by abusers, it can produce blurred vision, itching, rash, sweating, fever, and shallow breathing as well as increased blood pressure, heart rate and body temperature. It also can produce hallucinations, loss of motor control and in some cases, death, according to the American Society of Anesthesiologists (ASA), which released guidelines in July to help parents recognize signs that their children might be Robo tripping.
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