FDA changes label safety requirements on prescription opioid, cough medicines

Cough syrup and a spoon are seen in this file

Cough syrup and a spoon are seen in this file

The U.S. Food and Drug Administration has announced that it is requiring safety labelling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products", he said. 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.

Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age. However, she said the dangers to children from opioids have been long known _ not only the threat of addiction and breathing risks, but unpredictability of how individual children will metabolize the drugs. 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. "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.

The FDA also says the new changes 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 April, the FDA announced that it was strengthening labeling on codeine and tramadol, both opioid pain relievers, to protect young children and nursing babies from breathing problems arising from the medications' use.

"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. After the safety labeling changes are made, the products will no longer be indicated for use to treat coughs in any pediatric population.

The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine.

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. Some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own _ including ones that are the result of respiratory infections.

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

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