On August 21, 2017, the FDA Commissioner Scott Gottlieb, M.D., announced that the FDA would be reevaluating prescription opioid medications approved to treat children’s coughs.
At a roundtable earlier in 2017, 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 is causing the symptoms, rather than just quieting the cough. 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 on August 21, 2017, 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 FDA’s decision-making processes related to these medications.
The FDA is continuing to evaluate the potential complications that can occur when using opioid-containing medications in children, even according to labeled instructions. As part of these efforts, the FDA announced in Aprils 2017 required changes 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.
See the FDA Announcement
See also Medical Law Perspectives Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See the Medical Law Perspectives Blog: Risks of Prescription and OTC Pain Medicines During Pregnancy
See the Medical Law Perspectives Blog: Pharmacy Owes Duty To Patient Not To Fill Excessive Prescriptions for Opioids
See the Medical Law Perspectives Blog: Opioid Pain Pill Abusers Switch to Heroin; Heroin Overdose Deaths Double