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Cough-Syrup Abuse by Kids May Draw FDA Restrictions for Pfizer, J&J Drugs

Enlarge image ‘Robo-Tripping’ Fears May Result in Controls

‘Robo-Tripping’ Fears May Result in Controls

‘Robo-Tripping’ Fears May Result in Controls

Scott Olson/Getty Images

Robitussin cough medication may be reviewed for possible U.S. dispensing restrictions because of increasing signs of abuse and injuries among adolescents.

Robitussin cough medication may be reviewed for possible U.S. dispensing restrictions because of increasing signs of abuse and injuries among adolescents. Photographer: Scott Olson/Getty Images

Pfizer Inc.’s Robitussin and Johnson & Johnson Tylenol Cough may be reviewed for possible U.S. dispensing restrictions because of increasing signs of abuse and injuries among adolescents.

Non-medical use of dextromethorphan, a common cough suppressant approved since 1958, accounted for an estimated 7,988 emergency room visits in 2008, up from 4,634 in 2004, according to a U.S. government report yesterday. A Food and Drug Administration advisory panel will meet Sept. 14 to discuss whether the medicine should be a controlled substance.

Drugmakers have tried since 2006 to educate parents and teachers about dextromethorphan abuse, often referred to as “robo-tripping” or “skittling.” The FDA is collecting data on the scope of the problem in response to the Drug Enforcement Administration’s call for a recommendation on new restrictions.

“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 or to get ‘high,’” FDA staff said in the report. “Therefore, routine labeling changes or product packaging redesign will probably not reduce the present abuse trend.”

Dextromethorphan is in many nonprescription combination cold drugs, including Robitussin Cough & Chest Congestion from New York-based Pfizer; Tylenol Cough & Sore Throat from New Brunswick, New Jersey-based J&J; and Vicks NyQuil Cough from Cincinnati-based P&G. It is also sold as a single ingredient called Delsym by Berkshire, United Kingdom-based Reckitt Benckiser Group.

Burden on Consumers

Drug manufacturers say that making the medicine a controlled substance subject to federal restrictions will unnecessarily burden consumers.

“Our goal is to stop the intentional abuse of cough medicine while allowing for continued, responsible availability of these medicines,” said Elizabeth Funderburk, a spokeswoman for the Consumer Healthcare Products Association, in an e-mail yesterday. The Washington-based trade group represents companies that make over-the-counter drugs.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

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