FDA panel recommends against making Robitussin, others prescription drugs, despite abuse

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FDA panel: cough meds should stay over-the-counter

WASHINGTON — A panel of medical experts said Tuesday that cough medicines like Robitussin and Nyquil should continue to be sold over-the-counter, despite increased abuse among teenagers that has prompted calls to restrict sales of the products.

The Food and Drug Administration panel voted 15-9 against a proposal that would require a doctor’s note to buy medicines containing dextromethorphan, an ingredient found in more than 100 over-the-counter medications.

The FDA is not bound to follow the group’s advice, though it often does. Specifically, panelists were asked if the ingredient should be “scheduled,” a regulatory move designed to decrease access to drugs with high potential for abuse.

“For me there was no data to show us that scheduling this product would decrease abuse,” said panelist Janet Engle, professor and department head of pharmacy practice at the University of Illinois.

Abuse of dextromethorphan, dubbed “robotripping,” is popular among teenagers as an inexpensive way to get high, but it carries risks, including elevated blood pressure, heart rate and fever. Abusers can also suffer side effects from other ingredients mixed in cough medicines, such as acetaminophen, which can cause liver damage.

Medical complications from the behavior are on the rise with nearly 8,000 emergency room visits reported in 2008. That was up more than 70 percent from reports in 2004.

“Many teenagers are thinking that because it’s a legal drug it must be safer to abuse, and that’s why we’re also seeing a growing trend in prescription drug abuse,” said Engle, in a telephone interview with The Associated Press.

The FDA agreed to revisit how it regulates the medicines at the behest of the Drug Enforcement Agency, which suggested making them prescription drugs.

But many of FDA’s panelists said making the drugs prescription-only would go too far — creating an enormous amount of extra work for doctors and pharmacists.

Dextromethorphan products were purchased by more than 40 million U.S. households last year. Popular brands containing dextromethorphan include Wyeth’s Dimetapp, Bayer’s Alka Seltzer Flu Plus and Procter & Gamble’s Vicks cough medicines. The drug is available in pills, gel caps, liquids and other forms.

Surveys by cough medicine manufacturers show that less than 2 percent of youngsters ages 12 to 17 reported abusing dextromethorphan in 2008, far less than those abusing marijuana or prescription painkillers.

The Consumer Healthcare Products Association supports prohibiting sales of the medicines to people under age 18. Such age restrictions require legal changes, and the industry trade association has lobbied on the issue at the state and federal levels.