FDA changes label safety requirements on prescription opioid, cough medicines

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"The U.S. Food and Drug Administration 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", it said in a statement. "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", said FDA Commissioner Scott Gottlieb, M.D.

After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18. Cough and cold medicines that have opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age. These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.

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

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

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. 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. For those children in whom cough treatment is necessary, alternative medicines are available. "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". Always read the labels on prescription bottles.

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