US FDA Adds New Warnings on Children’s Cough and Cold Medicine that Contain Codeine

The United States Food and Drug Administration has announced some major changes on the way to labeling requirements on certain children’s medications.

This week, the agency has added new requirement that serves to limit the number of children who can use a prescription opioid cough medicine as well as cold medicines that contain codeine and/or hydrocodone.

As described in the announcement, the agency is in the process of updating the labeling for these medications to include additional safety warnings for adult use in order to notify users about the inherent risks associated with misuse, abuse, addiction, overdose, and death.

According to FDA Commissioner Scott Gottlieb, “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. It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. 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.”

He cites, also, the ongoing epidemic of opioid addiction across the country, stressing furthermore the importance of reducing potential exposure of these sensitive and addictive drugs to younger children.

Gottlieb continues, “Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction.”

It should be noted, too, that this action really updates and adds to a previous warning issued by the FDA in April which warned against the use of such prescription medications (containing codeine or tramadol) for children under the age of 12.  At this time, officials had shared concerns that some children might be “ultrarapid metabolizers,” which means they can process these drugs very quickly—faster than other children—which could result in dangerously higher levels of concentrate drugs in their system, leading to breathing depression and even death.

At the end of the day, the agency urged that parents read all labels on all prescription bottles, adding, “If the medicine prescribed for your child contains an opioid, talk to your child’s health care professional about a different, non-opioid medicine.”

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