FDA Revises Opioid Labeling to Restrict Pediatric Use


Cough and cold medicines containing codeine and hydrocodone are no longer indicated for use in pediatric patients.

The FDA yesterday announced that they are requiring labeling changes to reduce the use of opioid cough and cold treatments that contain codeine and hydrocodone in pediatric patients, according to a press release.

After the labeling changes are official, the treatments will no longer be indicated to treat pediatric patients. The agency is seeking to reduce use among younger patients due to the risk of serious adverse events.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children,” said FDA Commissioner Scott Gottlieb, MD. “We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The labeling for adult use of these drugs is also being updated to include an expanded boxed warning that alerts for the risk of misuse, abuse, addiction, overdose and death, and slowed breathing, according to the release.

The new labeling for adults will provide a safety warning that is consistent with other opioid-based drugs, including immediate-release opioid analgesics, and extended-release and long-acting opioid analgesics.

These changes are based on an in-depth review of data and expert advice about opioid-containing cough and cold treatments, according to the release.

Last year, the FDA required the addition of a contraindication to the labeling of these products to warn that they should not be used by children younger than 12 years due to ultra-rapid metabolism, according to the release.

The agency also held a roundtable to determine all of the risks associated with use of codeine- or hydrocodone-containing cough and cold products in patients younger than 18 years. The experts concluded that the risks of these products typically outweigh the benefits in children.

The FDA advises that parents of children currently taking cough and cold medicine containing codeine or hydrocodone should discuss alternative treatment options with their child’s health care provider.

This action is the latest push to combat the opioid epidemic through various platforms, including reducing exposure, preventing new addiction, supporting treatment for opioid use disorder, developing new pain treatments, and improving enforcement, according to the study.

“It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” Dr Gottlieb said. “At the same time, we’re taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products.”

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