FDA Requiring Changes To Prescription Opioid Cough And Cold Medicine Labeling

FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug…

The FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.

FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or hydrocodone.

Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.

FDA is taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

See the FDA Drug Safety Communication for a list of prescription cough and cold medicines containing codeine or hydrocodone

BACKGROUND: Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold. Other non-opioid prescription and OTC medicines are available to treat these symptoms.

RECOMMENDATION: Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated. These products will no longer be indicated for use in children, and their use in this age group is not recommended. Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available. These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products.

Parents and caregivers should 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. It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment. If a cough medicine is prescribed, ask your child’s health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. Always 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.

Healthcare professionals and patients are encouraged to 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: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178