September 1, 2010
Cough Medicines Should Be Restricted: FDA
US health regulators are working out possible restrictions on popular cough suppressants in hopes to stop cases of abuse that send thousands of people to the hospital each year.
The Food and Drug Administration posted its review on Tuesday of dextromethorphan, an ingredient found in over a hundred non-prescription medications that is often abused for its euphoric effects. "Robotripping," as it is known among abusers, involves taking more than 25 times the recommended dosage of a cold medicine. The problem is most often associated with teenagers.
High doses of the drug can cause increased blood pressure, heart rate and fever. Abusers can also suffer side effects from other ingredients found in cough medicines, such as acetaminophen, which is linked to liver damage.
The drug is typically viewed as a safe, easy-to-use medication. But the psychoactive effects it can cause, "is sought after by those seeking to alter their mental state," states the FDA in a review.
Inappropriate use of the ingredient was linked to roughly 8,000 emergency room visits in 2008, according to the FDA. That number was up by more than 70 percent from 2004.
Analysis by the FDA concluded that dextromethorphan is abused less often than the popular painkiller codeine, but, more often than pseudophedrine, a cold medicine ingredient that can be processed into methamphetamine.
The FDA is now looking to reconsider how it regulates the drug after the Drug Enforcement Agency raised concerns about the increasing abuse among adolescents.
The FDA will ask a panel of outside experts on September 14 whether dextromethorphan should be available only as a prescription. The agency is not required to follow the panel's advice, though it usually does.
Mandating a prescription for cough suppressants that have dextromethorphan would be a major upset for over-the-counter drug makers, which use the drug in dozens of cold medications.
Brands such as Wyeth's Dimetapp, Bayer's Alka-Seltzer Flu Plus and Proctor and Gamble's Vicks cough medicines all contain dextromethorphan. The drug is available in pills, capsules, liquids and other forms.
Most industry experts do not believe the FDA will impose a prescription on those products due to the enormous workload it would create for doctors and pharmacists.
A possible alternative would be to place such medicines behind the counter, although the FDA review did not disclose any specific proposals.
The over-the-counter industry supports the prohibition of sales of the medicines to people under the age of 18. Such age restrictions would require legal changes, and the industry's trade association has lobbied on the issue at the state and federal levels.
The Consumer Healthcare Products Association has been working to reduce abuse of over-the-counter drugs since 2003 by sponsoring educational campaigns that target parents, teenagers and school nurses, a spokeswoman for the agency told the Associated Press.
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