FDA Changes Safety Label for Pediatric Prescription Opioid Medication

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According to a new safety communication, the Food and Drug Administration (FDA) is requiring that changes be made to the labeling of prescription cough and cold medicines containing codeine and hydrocodone. The expert panel found that the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medications outweighed their benefits in patients 18 years of age.

The move is in response to the opioid addiction epidemic.

The required safety labeling changes announced today are based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products.

In addition to limiting use in children following a comprehensive assessment of the risks and benefits of these products, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

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. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.

Thursday's action expands a previous warning, issued by the agency last April, against the use of prescription medications containing codeine and tramadol for children younger than 12.

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The agency urged parents to read the labels on prescription bottles.

In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said.

The FDA will also carry bigger warning about their dangers to adults, NBC News reported. Experts noted that most pediatric cough symptoms that are caused by a cold or upper respiratory do not typically require treatment with these products.

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

Some over-the-counter therapies may contain codeine, or may not be appropriate for young children.

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