FDA Drug Information Update on Children's Prescription Opioid Cough Medications

PUBLISHED: Aug 22, 2017
Relevant to: Ambulatory Care, Community Mental Health Centers, Critical Access Hospitals, Home Health, Hospitals, Medical Office/Clinic, Pharmacies

The US Food and Drug Administration (FDA) has issued a drug information update informing health care providers and the public that they are carefully evaluating prescription opioid medications approved to treat cough in children. The FDA has 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.

According to the FDA, it is vital to 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.

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