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FDA: Giving Children Codeine Post-Surgery Raises Death Risk for Some | cialis online

FDA: Giving Children Codeine Post-Surgery Raises Death Risk for Some

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The U.S. Food & Drug Administration (FDA) has announced that treating children with codeine after surgery might increase their risk of death. To date three children—ages two to five—have died and one child suffered a nonfatal, but serious and life-threatening case of respiratory depression after codeine treatment following surgery to remove tonsils and/or adenoids.

The surgeries were performed to treat obstructive sleep apnea syndrome, a condition that results in repeated episodes of complete or partial blockage of the upper airway during sleep, the FDA explained. The children received codeine within the typical dose range.

The agency advises health care professionals and parents to be aware of the risks associated with codeine when treating children who have had their tonsils and/or adenoids removed to treat obstructive sleep apnea syndrome. Health care professionals should prescribe the lowest effective dose of codeine-containing drugs for the shortest time and on an as-needed basis. Should signs of overdose be seen, immediate medical attention should be sought. Overdose signs include unusual sleepiness, difficulty being aroused or awakened, confusion, or noisy and difficult breathing.

“The FDA is currently conducting a review of adverse event reports and other information 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,” Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products in FDA’s Center for Drug Evaluation and Research, said. “The FDA will update the public when more information is available.”

Codeine can be found in prescription medications used to relieve pain or cough. Once ingested, codeine converts to morphine in the liver by an enzyme called cytochrome P450 isoenyme 2D6 (CYP2D6). Some people metabolize codeine much quicker and more completely—so-called “ultra-rapid metabolizers”—and are likelier to have higher-than-normal levels of morphine in their blood after taking codeine. These 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 high levels can lead to overdose and death. The three children who died following codeine treatment showed evidence of being ultra-rapid metabolizers.

High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in ultra-rapid metabolizing children.

The estimated frequency of ultra-rapid metabolizers is about 1 to 7 out of every 100 people; in certain ethnic groups, the frequency may be as high as 28 out of every 100. FDA-cleared tests are available for determining a patient’s CYP2D6 genotype; this is the only way to determine if someone is an ultra-rapid metabolizer. A breakdown by ethnic group can be accessed at the agency’s Drug Safety Communication at:

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