FDA Requires Changes to Labeling for Opioid Cough and Cold Medicines

January 12, 2018

Changes designed to limit use of these medication for pediatric patients

The Food and Drug Administration (FDA) is requiring safety labeling changes to limit the use of prescription cough and cold medicines that contain codeine or hydrocodone in patients younger than 18 years old. The FDA is making this change because the risks of these medicines outweigh their potential benefits in this patient population. 

This change is based on an extensive review by the FDA of available data, outside expert advice, and a meeting of its Pediatric Advisory Committee on pediatric use of opioid-containing cough and cold medications. Conclusions indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.

Labeling for these products is also being updated with additional safety information for adults. The new Boxed Warning will be expanded to include notification of the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from codeine or hydrocodone. This labeling is consistent with labeling of other drugs containing opioids, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. 

Recommendations for health care professionals:

  • Be aware that the FDA is changing the age range for prescribing opioid cough and cold medicines. These products will no longer be indicated for use with patients under the age of 18. 
  • Reassure parents that cough due to cold or upper respiratory infection is self-limited and generally does not need to be treated.
  • Prescribe alternative medicines for children who need treatment. These alternatives include over the counter products, such as dextromethorphan, or prescription benzonatate products.

Recommendations for parents and caregivers:

  • Be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children. Codeine and hydrocodone are narcotic medicines called opioids and may carry serious risks when used in children. 
  • Understand that a cough due to a common cold often does not need medicines for treatment. 
  • Ask your child’s health care professional or a pharmacist if a prescribed cough or cold medication contains an opioid such as codeine or hydrocodone. 
  • Read the labels on prescription bottles. If the medicine prescribed for your child contains an opioid, talk to your child’s health care professional about a different, non-opioid medicine, or if you have any questions or concerns.

Recommendations for health care professionals, parents, and caregivers:

  • Report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. 
    • Complete and submit the report online.
    • Download the form or call 1-800-332-1088 to request a reporting form; complete and return the form to the address on the form or submit by fax to 1-800-FDA-0178.

Learn more on the FDA website

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