Tuesday, 23 January, 2018

FDA Is Trying To Keep Cough Medicines Containing Opioids From Kids

FDA revises labelling in prescription cough and cold products to protect children from opioids FDA warns against giving kids cough and cold medicines with codeine or hydrocodone
Patty Aguilar | 12 January, 2018, 10:16

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 U.S. Food and Drug Administration is requiring increased safety labeling on cough and cold medicines to protect kids from opioids. The makers of these medicines also will need to update their labeling to provide safety warnings consistent with the labeling of other opioid-containing drugs, and will feature an expanded Boxed Warning for adult use. 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 FDA said it conducted extensive reviews of available data and sought expert advice on opioid use in the treatment of childhood pain and cough.

The FDA recommends OTC products, such as dextromethorphan, as well as prescription benzonatate products when cough treatment is necessary.

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

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 noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels.

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