Regulatory Focus™ > News Articles > FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

Posted 11 January 2018 | By Zachary Brennan 

FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

“We are taking this action after conducting an extensive review and convening a panel of outside experts. Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18,” FDA said.

Some codeine cough medicines are available over the counter in a few states, FDA noted, saying it is also considering regulatory action for these products.

“Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated. For those children in whom cough treatment is necessary, alternative medicines are available.  These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products,” the safety communication said.

Back in April, FDA announced label changes to two opioids: codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks.

FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older


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