FDA changes label safety requirements on prescription opioid, cough medicines

FDA changes label safety requirements on prescription opioid, cough medicines

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children".

The most commonly experienced side effects by patients using either of these drugs are sleepiness, nausea, vomiting, labored breathing, and others.

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.

According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers. We know that any exposure to opioid drugs can lead to future addiction.

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

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Medicines containing codeine or hydrocodone are now required to have a label indicating they're for people age 18 and over.

The organization announced that it will require safety labeling changes on medications containing certain drugs because they could pose serious risks for children under the age of 18.

Last April, the FDA required that a contraindication - the administration's strictest warning - be attached to prescription codeine and tramadol medicines. 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.

Gottlieb said in a statement in August that the FDA would be meeting with the Pediatric Advisory Committee to further evaluate the use of prescription opioid products containing hydrocodone or codeine to treat cough in children. And while they say some kids' cough require treatment, symptoms usually subside on their own. For those children in whom cough treatment is necessary, alternative medicines are available.

Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options.

The agency urged parents to read the labels on prescription bottles. "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription". Some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children.



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