Last week the FDA called a joint meeting of its Nonprescription drugs and Pediatric advisory committees to discuss recent death and illness reports allegedly linked to over-the-counter (OTC) cough and cold medications for infants and children.
Due to the reported deaths and illnesses associated with use of OTC cold and cough rememdies, the infant versions of these drugs have already been withdrawn from store shelves.
Dr. Lurie, deputy director of the Health Research Group at Public Citizen, a national nonprofit public interest organization, spoke at the meeting, recommending that children under age 12 not be given OTC cough and cold medications. Dr. Lurie pointed out that there are only 11 pediatric clinical trials involving these types of medications to be found over the past 50 years.
“No matter which path to pediatric approval a cough and cold drug may attempt to take, there is simply no evidence to support the position that these drugs are safe and effective for children,” said Lurie. “In fact, recent data have shown just the opposite – that these drugs often cause serious harm.”
The FDA advisory panel voted 13 to 9 that children ages 2 to 6 should not use OTC cold and cough drugs, including antihistamines, decongestants, antitussives and more. The concensus was that the drug risks outweigh the benefits, and not enough studies have been conducted to explore their effects on children.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.