FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use.

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

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections.

The move is in response to the opioid addiction epidemic. For those children in whom cough treatment is necessary, alternative medicines are available. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

Gottlieb added that the FDA is taking steps to assure parents that treating the common cold or cough is possible without prescription opioid medicine. "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription".

Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

In a few states, codeine cough medicine is still available for over-the-counter (OTC) dispensing.

The label change also proceeds a pediatric restriction set a year ago that required a contraindication to prescription codeine product labels. The agency continues its ongoing efforts to reduce the scope of the epidemic of opioid addiction on several fronts, including decreasing exposure and preventing new addiction, supporting treatment for those with opioid use disorder, fostering development of novel pain therapies, and improving enforcement.

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