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Drug Industry Proposal for Cough and Cold Medications Will Not Protect Children

Oct. 7, 2008

Drug Industry Proposal for Cough and Cold Medications Will Not Protect Children

Statement of Peter Lurie, M.D., MPH, Deputy Director of the Health Research Group at Public Citizen*

Today, the leading manufacturers of over-the-counter cough and cold medications indicated that they are “voluntarily transitioning” toward putting a label on their pediatric products that instruct parents not to give the medications to children under 4. This measure, announced by the Consumer Health Products Association (CHPA), clearly represents a political compromise, not a solution based on scientific evidence. It will do little to protect all children from these ineffective and, therefore, needlessly dangerous products.

By announcing a 4-year-old age restriction – halfway between the current voluntary limit of 2 years of age and the age limit of 6 requested in a petition submitted last year – the manufacturers are once again attempting to delay more definitive action by the Food and Drug Administration (FDA). The FDA must use its authority to make a strong, evidence-based decision not to allow these medications to be available to children under 12, rather than let the industry engage in this type of self-serving self-regulation.

A year after manufacturers of over-the-counter (OTC) cough and cold medications agreed to voluntarily withdraw their products for children under 2 from the market, a small Public Citizen survey found that less than a quarter of cough and cold medications on sale in two major pharmacies in Washington, D.C., and Baltimore, Md., carried labels warning parents not to use these medications in children 2 or younger. We have no confidence that today’s proposed “voluntary” measures by members of the CHPA (which does not represent all manufacturers of OTC cough and cold medicines, particularly generic ones) will be any more effective. Moreover, CHPA proposes to leave the medications on pharmacy shelves “throughout the 2008-2009 cough and cold season,” allowing the companies to reduce their inventories.

By instructing parents not to give these medications to children under 4, the new label sends the message that these medications are “safe and effective” for children 4 and over. This assertion is not true. Reviews by FDA Medical Officers and a more recent published study demonstrate that OTC cough and cold medications have not been proven to be effective in children under 12. In light of this ineffectiveness, any toxicity is unacceptable. The FDA needs to take a firmer stance to modify the regulations governing these products and must ensure that they are removed from the market unless new evidence proves them safe and effective. Unless the agency acts more expeditiously and forcefully, we will continue to see more unnecessary emergency room visits and deaths, and the annual squandering of hundreds of millions of dollars.

*Last week, Dr. Lurie submitted testimony to an FDA advisory committee on this subject. To read Public Citizen’s recent testimony before the FDA, go to https://www.citizen.org/our-work/health-and-safety/articles/testimony-cough-and-cold-remedies-children.