FDA warns against kids' cough medicine with codeine, hydrocodone

Leslie Hanson
January 13, 2018

On Thursday, the FDA announced it is requiring the changes in order to limit the number of children using prescription opioid cough medicines and cold medicines containing codeine and hydrocodone. They believe the risks outweigh the benefits.

The FDA announced yesterday that it is requiring revisions to the safety labeling on such perscription opioid cough and cold medicines.

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".

The FDA is also asking companies to add new safety warning labels on medicines for adults, including an expanded boxed warning, which describes the risks of taking those that include codeine and hydrocodone.

After the labeling changes, the products will be indicated to only be used for adults.

Some codeine cough medicines are available OTC in a few states, and FDA 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.


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. Make sure it doesn't include codeine or hydrocodone, because the Food and Drug Administration says the opioid ingredients could pose some serious safety risks.

It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment.

The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or a hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old. Always read the labels on prescription bottles.

In 2013, the FDA issued a public warning and implemented a "black box warning" - the strongest safety statement - against prescribing codeine to children for pain management after having their tonsils or adenoids surgically removed.

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.

Other reports by Iphone Fresh

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