An article in the December 6, 2007 issue of the New England Journal of Medicine (NEJM) calls for the US Food and Drug Administration (FDA) to take action concerning over the counter pediatric medications targeted at children under 12 years of age. “We believe that it (FDA) should immediately ask companies to remove these products from store shelves and begin legal proceedings to require them to do so.”
The original NEJM article by by Joshua M. Sharfstein, M.D., Marisa North, B.A., and Janet R. Serwint, M.D., highlights some very interesting facts related to over the counter drugs being advertised for children. The article notes that, “Since 1985, all six randomized, placebo-controlled studies of the use of cough and cold preparations in children under 12 years of age have not shown any meaningful differences between the active drugs and placebo.”
The NEJM article noted that as far back as 1997, the American Academy of Pediatrics created a policy statement on cough medications stating “indications for their use in children have not been established.” Additionally, the authors of the article noted that as recently as 2006, the American College of Chest Physicians stated that “literature regarding over-the-counter cough medications does not support the efficacy of such products in the pediatric age group.”
Some additional and chilling statistics brought forth in the article note that since January of 2000 there have been 750,000 calls of concern related to cough and cold products to poison-control centers. Additionally they reported that the US Centers for Disease Control and Prevention in 2004 and 2005 identified more than 1500 emergency room visits for children under 2 years of age related to cough or cold products.
The article notes that in 1976, the FDA adopted a system for determining children’s medications doses using a crude formula. This formula simply determined the use of pediatric medication by age only. For children between 6 and 11 years of age, the formula said that medications should be dispersed based upon half the adult dose. For children between 2 and 5 years of age, the formula recommended a quarter of the adult dose. The NEJM article notes that this very crude formulation was not based upon any science and has not been changed for over 30 years.
Interestingly, the New England Journal of Medicine article was also reported in several Canadian news outlets but NOT in any major US news publications. In a December 06, 2007 article in the Canadian National Post, Dr. Michael Rieder of the Canadian Pediatric Society commented on the importance of this NEJM article by stating, “Every regulator in the world will pay attention to [the article], and because we share the same unprotected border, Canada will pay more attention than other countries. The pressure has been building to this for over the past 12 to 18 months, and people in the community are saying, ‘Let’s get this done.'”