FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.
Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. 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.
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. 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.
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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. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone.
In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18. They expand pediatric restrictions put in place last year when the FDA required the addition of the FDA's strongest warning, called a contraindication, to the labeling of prescription codeine products alerting 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. And while they say some kids' cough require treatment, symptoms usually subside on their own.
"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", he said.
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Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death.
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.
Some codeine cough medicines are available OTC in a few states, and FDA is also considering regulatory action for these products.
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Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol.