FDA Bans Use of Opioid-Containing Cough Meds by Kids

From Drugs.com - January 11, 2018

FDA Bans Use of Opioid-Containing Cough Meds by Kids

THURSDAY, Jan. 11, 2018 -- Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

These prescription medicines involve any that include codeine or oxycodone, the FDA said.

"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.

The newly updated Boxed Warning on these medicines will also warn adult users "about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone," the agency added.

"Given the epidemic of opioid addiction, we are concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that do not justify their use in this vulnerable population," FDA Commissioner Dr. Scott Gottlieb said in the news release.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone," he added. "At the same time we are taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products."

The move comes after a 2017 decision by the FDA to add its strongest warning -- a "contraindication" -- to labeling for prescription products containing codeine. That labeling restricted use to children aged 12 and over "due to a specific risk of ultra-rapid metabolism in certain patients," the FDA explained.

The new rules announced Thursday were "based on an extensive review of available data and expert advice," the agency said.

They go much further than the 2017 labeling rules -- restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said.

"Experts indicated that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment," the agency said. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits."

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