Federal Drug Administration Announces New Safety Labels For Codeine, Hydrocodone

Federal Drug Administration Announces New Safety Labels For Codeine, Hydrocodone

FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or hard breathing to the Boxed Warning, the most prominent warning, of the drug labels for prescription cough and cold medicines containing codeine or 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.

Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated.

According to the announcement, labeling for those medications is also being updated with additional safety warning for adult use notifying users about the risks of misuse, abuse, addiction, overdose, and death, along with slowed or hard breathing.

It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment.

The FDA announced yesterday that it is requiring revisions to the safety labeling on such perscription opioid cough and cold medicines. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems.

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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. 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. Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.

So what's the advice for parents who may be using these medicines for their child already? 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. According to the FDA, they should talk to their child's doctor about alternative therapies.

Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

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

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