FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

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Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

The labeling is also being revised with an expanded Boxed Warning about the risks of misuse, abuse, addiction, overdose and death and slowed/difficult breathing that can result from exposure to the opioids in adult patients.

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. The new safety guidelines will state that the products will no longer be indicated for pediatric patients.

The U.S. Food and Drug Administration is requiring increased safety labeling on cough and cold medicines to protect kids from opioids. We know that any exposure to opioid drugs can lead to future addiction.

Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine.

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Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA.

One physician who's dealt with the aftermath of opioid overuse applauded the move.

The FDA will also carry bigger warning about their dangers to adults, NBC News reported.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18. 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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