Cough Syrup Containing Opioids Is Dangerous for Kids: FDA

FDA Orders Labeling Changes For Certain Cough And Cold Medicines

The FDA is putting new limits on the amount of prescription cold and cough medicine that children should be given.

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. 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. 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.

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

"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", the FDA said in a news release. "For those children in whom cough treatment is necessary, alternative medicines are available", including OTC products such as dextromethorphan as well as prescription benzonatate products.

Now, the FDA's latest action to revise safety labeling on some prescription cough and cold products expands the pediatric restrictions that were previously in place.

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.

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Parents whose children are now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options, the FDA advised.

One physician who's dealt with the aftermath of opioid overuse applauded the move.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

"The opioid epidemic has many origins, but can begin with exposure to [opioids] at young ages", he said.

Then, last year, the agency warned that the opioids codeine and tramadol could cause life-threatening breathing problems in children and strengthened drug labeling to restrict their use in children younger than 12.

It's always important to read medicine labeling, too - even if it's not obtained by prescription.

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