Published: Sat, January 13, 2018
Medicine | By Brett Sutton

FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

"These include over-the-counter (OTC) products such as dextromethorphan, as well as prescription benzonatate products", the safety communication said.

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

The label change also proceeds a pediatric restriction set a year ago that required a contraindication to prescription codeine product labels.

The new requirements build on previous restrictions enacted by the agency last year, when the FDA required the addition of a contraindication warning to the labeling, to warn against use in children younger than 12 years old due to risk of ultra-rapid metabolism in certain patients.


"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".

FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone. We know that any exposure to opioid drugs can lead to future addiction.

The FDA will also carry bigger warning about their dangers to adults, NBC News reported. According to the FDA, they should talk to their child's doctor about alternative therapies.

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.

Like this: