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FDA Issues Strongest Warning about Prescribing Codeine to Children

Posted on in Drugs

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

In August 2012, the FDA warned that there were some children that shouldn't be prescribed codeine after a tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome because it could lead to rare, but life-threatening adverse events or death.

Codeine is an opioid pain reliever and 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.

At the time of their original warning, the FDA had received three reports of children's deaths and one case of severe respiratory depression. The children were between two and five years old.

Since then, 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.

Due to the number of children affected, the FDA has now issued a boxed warning, the strongest warning the agency can issue. This warning 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 FDA 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 warning parents to request a different pain medication if their child is prescribed codeine.

If your child has had reactions from being prescribed a dangerous medication, contact an experienced Illinois dangerous drug attorney to find out how the physician responsible can be held accountable for your child's pain and loss.

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