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FDA Issues its Strongest Warning against Prescribing Codeine to Children

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What happened:

The U.S. Food and Drug Administration (FDA) has issued an update to a warning they issued in August 2012 regarding the administration of codeine to children.

In the original warning, the FDA announced that in codeine use in certain children after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome may lead to rare, but life-threatening adverse events or death.

Codeine, an opioid pain reliever, is converted to morphine by the liver. Some children are “ultra-rapid metabolizers of codeine” and this can cause the liver to convert codeine into life-threatening amounts of morphine in the body, leading to a fatal morphine overdose.

When the FDA issued the warning in August, they had received three reports of children’s deaths and one case of severe respiratory depression. The children ranged in age from two to five years old.

Since that warning, a review of the FDA database has determined that from 1969 to May 1, 2012, there were ten deaths and three overdoses associated with codeine. Many of these children were recovering from a surgery to remove their tonsils or adenoids.

 

The North Carolina Injury Lawyer Perspective:   

The FDA has nowissued a boxed warning – which is the agency’s strongest warning – that will be added to the drug label of codeine-containing products about the risk of codeine to manage pain in children after a tonsillectomy and/or adenoidectomy. The agency is strongly recommending against the use of codeine as a pain manager for children after a tonsillectomy and/or adenoidectomy and asks physicians to use an alternate pain reliever.

The agency is also recommending that parents ask for a different pain medicine if their child is prescribed codeine in the medical circumstances described. If your child has had reactions from being prescribed a dangerous medication, contact a North Carolina attorney to find out how the physician responsible can be held accountable for your child’s pain and loss.

 

FDA Headquarters, Silver Spring, MD


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Helpful Info:

If you or a family member was seriously injured by a defective or dangerous drug, you can begin to learn about your legal rights and options by reading this article.

Have Questions?

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