FDA: Prescription Opioid Cough/Cold Meds No Longer Indicated for Children

Henrietta Strickland
January 13, 2018

Citing the risks to patients younger than 18 years old, the FDA is requiring labeling changes to prescription cough and cold medications that contain codeine or hydrocodone. "Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18", FDA said. For those children in whom cough treatment is necessary, alternative medicines are available.

The label change also proceeds a pediatric restriction set previous 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.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. 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 side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

One physician who's dealt with the aftermath of opioid overuse applauded the move. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients. Information about these required safety labeling changes are being made available to parents and health care professionals through a Drug Safety Communication. Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.

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