Cough Syrup Doesn’t Need Restrictions, US FDA Panel Says
5:09 pm in medical news by admin
Abuse of cough suppressants such as Pfizer Inc.’s Robitussin and Johnson & Johnson’s Tylenol Cough doesn’t warrant new distribution restrictions, a U.S. panel said.
The cough medicines are among the drugs containing dextromethorphan that should remain available over the counter rather than being classified as controlled substances, outside advisers to the Food and Drug Administration said today in a 15- 9 vote in Adelphi, Maryland. While the agency often follows its advisory panels’ recommendations, it isn’t required to do so.
Dextromethorphan, approved in the U.S. more than 50 years ago, is used in about 125 over-the-counter cough and cold medicines, according to an Aug. 31 FDA staff report. The Drug Enforcement Administration has cited an increase in adolescent dextromethorphan abuse, often called “robo-tripping.”
“There’s a low level of abuse, and I think we need to have a scalpel to address the problem, not a big hammer,” panelist Warren Bickel, director of the University of Arkansas for Medical Sciences’ Center for Addiction Research in Little Rock, Arkansas, said after the vote.
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