FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

Henrietta Strickland
January 13, 2018

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or hard breathing that can result from exposure.

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

The affected products are sold by certain generic drug makers.

Those medications include codeine and oxycodone.

The FDA announced Thursday that it's requiring revisions to the safety labeling on such prescription opioid cough and cold medicines to indicate that the products no longer can be used to treat children - because their risks outweigh their potential benefits - and should be used only for adults 18 and older. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.

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

Today's announcement follows an extensive review conducted by the FDA's Pediatric Advisory Committee on the benefits and risks associated with opioid antitussive use in pediatric patients. After the labeling changes are made, these products will no longer be indicated for use to treat cough in children and will be labeled for use only in adults aged 18 years and older. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.

Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.

There's more about this issue at the American Academy of Pediatrics.

Other reports by Click Lancashire

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