AAP pushes for DXM restrictions

Regulators should restrict dextromethorphan for pediatric use because the cough suppressant's lack of efficacy does not outweigh the potential for abuse by adolescents or the risk of unintentional overdose, the American Academy of Pediatrics argues in 1comments submitted Aug. 30 to FDA. The academy hopes the Drug Safety and Risk Management Advisory Committee will consider its comments at the Sept. 14 meeting to discuss the safety of DXM and its potential for abuse (see story p. 6) (2"The Tan Sheet" Sept. 6, 2010). The academy points to the "cumulative evidence" of three studies that found DXM does not relieve children's cough and cold symptoms better than a placebo. AAP discounts four other studies that show the ingredient helped children because the studies have methodological flaws that would not meet current standards for research or publication. Sidney Wolfe, director of Public Citizen's Health Research Group and the consumer representative on DSaRM, noted one of these studies tipped the balance for him to classify DXM as "do not use" in his book "Worst Pills, Best Pills: A Consumer's Guide to Avoiding Drug Induced Death." Wolfe will not attend the meeting due to a scheduling conflict (3"The Tan Sheet" Aug. 30, 2010)