FDA: Deaths Linked to Codeine in Children

The Food and Drug Administration is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome.

There are reports of three recent pediatric deaths and one non-fatal but life-threatening case of respiratory depression. These children, who were ages two to five, had evidence of an inherited ability to convert codeine into life-threatening or fatal amounts of morphine in the body, according to an FDA press release. All children received doses of the drug that were within typical dose range.

When codeine is ingested, it is converted to morphine in the liver by an enzyme called cytochrome. Some people have DNA variations that make this enzyme more active, causing codeine to be converted to morphine faster and more completely than in other people. These “ultra-rapid metabolizers” are more likely to have higher than normal amounts of morphine in their blood after taking codeine.

High levels of morphine may result in breathing difficulty, which may lead to death. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.”

The FDA is currently conducting a safety review of codeine to determine if there are additional cases of inadvertent overdose or death in children taking codeine, and if these adverse events occur during treatment of other kinds of pain, such as post-operative pain following other types of surgery or procedures.

If your child has been injured by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you. For legal help, call (800) 581-6358.

Tags: