Federal Drug Administration Announces New Safety Labels For Codeine, Hydrocodone

New safety labeling requirements about who should take prescription opioid cough and cold medicines with codeine or hydrocodone are due to roll out following a United States Food and Drug Administration announcement.



The safety labeling changes will require that the medicines have labels that no longer indicate that such drugs are appropriate for anyone under the age of 18. 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.

Codeine is a pain reliever that is sometimes used in combination with other medications to treat severe cough, according to the FDA. Hydrocodone, also known as Vicodin, is a prescription opioid used to treat more severe pain, said the Centers for Disease Control. 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. People who take them run the risk of misuse, addiction, overdose and possible death.

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. 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.

The changes in the labeling requirements were decided upon after extensive research on the topic and the safety risks, including advice from experts, said the release from the FDA. Experts and pediatricians advised that while coughs in those under 18 sometimes do require treatment, usually the coughs were caused by a cold or upper respiratory infection; the risks of the opioid medication would outweigh benefits.

The most commonly experienced side effects by patients using either of these drugs are sleepiness, nausea, vomiting, labored breathing, and others. Last year the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA’s most severe warning, to say that it should not be used for patients under the age of 12. That warning was added because children are at risk for ultra-rapid metabolism, the newest announcement and expansion of labels is an expansion of that warning, said the FDA.

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