Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is carefully evaluating prescription opioid medications approved to treat cough in children

FDA Statement

• For Immediate Release: August 21, 2017

There’s perhaps no more important mandate that we have at the FDA than safeguarding the health and safety of children. For that reason, I believe it’s important that parents and health care providers have the best information available to inform the decisions they make about a child’s health. There are few more common decisions that parents and providers are asked to make than the question of how to appropriately treat a child’s cough and cold symptoms. Sometimes symptoms can be severe enough that prescription medication is needed, but some of these medications pose their own risks – especially for younger children – because they may contain opioids. Other times medication might not be necessary at all.

At a roundtable earlier this year, the FDA heard from professional groups, including the American Academy of Pediatrics and the American Academy of Family Physicians, about the use of cough suppressants, and in particular opioid cough suppressants, in children. Some of the key points focused on determining the right treatment based on the length and severity of the symptoms, as well as treating what’s causing the symptoms, rather than just quieting the cough. And depending on the situation, representatives suggested that other medications or non-drug therapies may be more appropriate.

To more carefully consider this complex issue, the FDA today announced an upcoming meeting of the Pediatric Advisory Committee that will focus on the use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients, including current treatment practices and benefit-risk considerations. The panel of independent experts will provide valuable input to help inform the agency’s decision-making processes related to these medications.

It is vital we understand the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions. This is an area that the agency is continuing to evaluate. As part of these efforts, the FDA announced required changes in April 2017 to the labeling of prescription codeine products in order to help better protect children from serious risks associated with these opioid medications, including life-threatening respiratory depression and death. Those changes include adding a contraindication to drug labels alerting that codeine should not be used for any reason, including treatment of cough, in children younger than 12 years. 

The FDA has also provided tips for consumers on how to safely treat a child’s cold as most young children do not need medicines to treat a cough or cold. Caregivers should read labels on non-prescription cough and cold products that may be sold over the counter as these products may contain codeine or may not be appropriate for young children. The FDA is also funding research to develop comprehensive, consumer-centered approaches on best practices for the safe use of pediatric cough and cold medications generally – not just those that contain an opioid.

All of this work is essential to reducing preventable harm from opioid-containing medications and keeping children safe. We look forward to a robust discussion at the meeting this fall and will continue to share updates with the public on the steps the agency is taking to address this important issue.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.