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

The U.S. Food and Drug Administration is requiring increased safety labeling on cough and cold medicines to protect kids from opioids.

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.

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

In 2013, the FDA issued a public warning and implemented a "black box warning" - the strongest safety statement - against prescribing codeine to children for pain management after having their tonsils or adenoids surgically removed.

The study included data on 362,992 privately insured children who had undergone those surgical procedures.

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

According to a statement from the agency, the safety labeling changes are meant to limit the use of these medications in children younger than 18 years old, as these products could be associated with risks.

The FDA also recommended against the use of these medications by women who are breastfeeding.

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use. The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old.

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.



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