On December 6, 2007, the New England Journal of Medicine published an article addressing the long-overdue reassessment of over the counter (OTC) pediatric cough and cold medications.

More than 95 million packages of medications for children are purchased each year. However, concern over the effectiveness and safety of these medications has continued for more than two decades.

In October 2007, major manufacturers of these OTC pediatric medications voluntarily recalled products for children under two, and proposed an additional warning ?[D]o not use to sedate children,? on antihistamine labels.

The article reported a lack of clear evidence that the benefits of taking OTC pediatric cough and cold medications outweigh the risks involved in giving such drugs to children under 12 years of age. Six randomized placebo?controlled studies, dating back to 1985, failed to show any meaningful differences between OTC pediatric medications and placebos.

Although efficacy has not been established for cough and cold medications in the pediatric age group, United States poison-control centers have reported more than 750,000 calls of concern related to OTC pediatric cough and cold medications since January of 2000. Recent reports from the Centers for Disease Control and Prevention (CDC) revealed more than 1500 emergency room visits in 2004 and 2005 for children under 2 years of age for cough and cold related product incidents.

Ingredients in OTC cough and cold products have been linked to serious life-threatening events in children under six. Specifically:

• Decongestants have been linked to cardiac arrhythmias and other cardiovascular events;
• Antihistamines have been linked to hallucinations; and
• Antitussives (cough medications) have been linked to depressed levels of consciousness and encephalopathy.

In addition, the FDA found 123 reports of deaths in children under six related to the use of OTC cough and cold medications over the past several decades. Serious adverse effects included accidental overdose, inadvertent misuse, and drug to drug or drug to host interactions.

In the 30 years that OTC cough and cold medications have been marketed for use in children, the FDA has yet to reevaluate the effects the drugs have on the pediatric population.

Source: Joshua Sharfstein, Marisa North, and Janet Serwint, ?Over the Counter but No Longer under the Radar ? Pediatric Cough and Cold Medications,? New England Journal of Medicine, December 6, 2007.