FDA warns against giving kids cough and cold medicines with codeine, hydrocodone

Bottles of NyQuil left Tylenol center front and Theraflu right all containing acetaminophen appear together in Walpole Mass. Tuesday

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

FDA Commissioner Scott Gottlieb, MD, expressed concern for young children's unnecessary exposure to opioids in a statement.

"We are taking this action after conducting an extensive review and convening a panel of outside experts". We know that any exposure to opioid drugs can lead to future addiction.

They go much further than the 2017 labeling rules - restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.

Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients.


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

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

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 FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache". The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options. Some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children. 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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