Published: Fri, January 12, 2018
Medical | By Johnnie Horton

FDA Is Trying To Keep Cough Medicines Containing Opioids From Kids

FDA Is Trying To Keep Cough Medicines Containing Opioids From Kids

"The U.S. Food and Drug Administration is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18", it said in a statement. These changes include limiting the use of these agents to adults ≥18 years old, as well as the addition of new safety information regarding the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death to the Boxed Warning.

The move is in response to the opioid addiction epidemic.

"It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population", he said.

Medicines containing codeine or hydrocodone are now required to have a label indicating they're for people age 18 and over.

In 2015, the FDA also announced an investigation into the possible risks of using codeine-containing medicines to treat coughs and colds in children under 18.

The new warnings are consistent with the labels on other drug products with opioids, including painkillers.

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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.

In a few states, codeine cough medicine is still available for over-the-counter (OTC) dispensing. Common side effects of opioids include headache, dizziness and vomiting.

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 agency urged parents to read the labels on prescription bottles.

Now, the FDA's latest action to revise safety labeling on some prescription cough and cold products expands the pediatric restrictions that were previously in place. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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