FDA putting new limits on cold medicine for children

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The Food and Drug Administration warned Thursday that children and adolescents should not be prescribed cough and cold medicines containing codeine and hydrocodone because of serious safety risks posed by the opioid ingredients. "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.

Labeling for these medications will also be updated with additional safety information for adults, including an expanded boxed warning.

BACKGROUND: Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. 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.

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. At the time, officials expressed concerns that some children are "ultrarapid metabolizers" who process such drugs very quickly, resulting in dangerously high levels that can depress breathing and lead to death.

"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well", said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City.

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The required safety labeling changes announced today are based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products.

In its announcement, the FDA argued the risks associated with these medicines outweigh potential benefits, citing the fact that upper respiratory infections typically don't require treatment. 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.

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

Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children. For those children in whom cough treatment is necessary, alternative medicines are available. Previous 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.

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