Health Alert: FDA warns of opioids in cold medicines

Alicia Farmer
January 13, 2018

These medicines should only be used for adults 18 and older.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children". Both are opioids, meaning they're either derived from an opiate or they are synthetic, and are part of a family of narcotic drugs that are highly addictive.

The Food and Drug Administration warned Thursday that children and adolescents should not be prescribed cough and cold medicines containing codeine and hydrocodone because of serious safety risks posed by the opioid ingredients. Cold and cough medicines that contain either codeine or hydrocodone will also have to have the same labels as any other medicine that contains an opioid. "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". This alerts people that codeine should not be used to treat pain or cough in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients.

The new rules announced Thursday were "based on an extensive review of available data and expert advice", the agency said.

Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. And while they say some kids' cough require treatment, symptoms usually subside on their own. The decision to change the labeling was made in response to the fact that the "serious risks of these medicines outweigh their potential benefits in this population", said the announcement from the FDA.

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Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

One physician who's dealt with the aftermath of opioid overuse applauded the move.

The revised safety warnings on these products will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics, according to the FDA.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said. For those children in whom cough treatment is necessary, alternative medicines are available.

The agency urged parents to read the labels on prescription bottles.

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