Cough Syrup Containing Opioids Is Dangerous for Kids: FDA

13 January, 2018, 15:41 | Author: Sherman Richardson
  • Bottles of NyQuil left Tylenol center front and Theraflu right all containing acetaminophen appear together in Walpole Mass. Tuesday

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

Furthermore, labeling for these products will now include an expanded Boxed Warning, explaining "the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing" that can result - even in adults.

The new requirements build on previous restrictions enacted by the agency last year, when the FDA required the addition of a contraindication warning to the labeling, to warn against use in children younger than 12 years old due to risk of ultra-rapid metabolism in certain patients.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well.

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The agency urged parents to read the labels on prescription bottles. The administration advises parents children prescribed codeine or hydrocodone to talk their health care professional about alternate treatment options.

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 held a risk-association discussion with its Pediatric Advisory Committee, during which experts indicated that cough due to colds or upper respiratory infections generally did not require treatment, and that the risks of prescription opioid cough therapy use did not outweigh its potential benefits. Common side effects of opioids include headache, dizziness and vomiting.

One physician who's dealt with the aftermath of opioid overuse applauded the move.

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

So what's the advice for parents who may be using these medicines for their child already?

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