The United States FDA Recommends Labeling Changes For Cough And Cold Drugs Containing Opioids To Protect Children

On January 11, 2018, the United States Food and Drug Administration (US-FDA) announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years of age because the serious risks of these medicines outweigh their potential benefits in this population57. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications is being updated with additional safety information for adult use - including an expanded Boxed Warning, FDA's most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

The FDA Commissioner said that given the epidemic of opioid addiction and knowing that any exposure to opioid drugs can lead to future addiction, the agency is concerned about unnecessary exposure to opioids, especially in young children.. It has become clear that the use of opioid-containing prescription medicines to treat cough and cold in children comes with serious risks that does not justify their use in this vulnerable population; making it critical to protect children from unnecessary exposure to such medicines.

In addition to limiting use in children, following a comprehensive assessment of the risks and benefits of these products, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also include updated safety information. The new labeling will provide safety warnings on these products that are consistent with the labeling of other opioid-containing drug products, including immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. Information about these required safety labeling changes are being made available to parents and health care professionals through a Drug Safety Communication.

The required safety labeling changes announced are based on an extensive review of available data and expert advice. The expanded pediatric restrictions were put in place last year58, when the FDA required the addition of its strongest warning, called a contraindication, to the labeling of prescription codeine products alerting that codeine should not be used to...