FDA Determines Codeine, Tramadol Unsafe For Children

Apr 22, 2017, 01:42
FDA Determines Codeine, Tramadol Unsafe For Children

The Food and Drug Administration on Thursday sharply ratcheted up its warnings about giving children prescription medicines with codeine and tramadol, saying the drugs could cause severe breathing problems and death.

Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research said in a statement that they have discovered that some children who take medicine containing codeine or tramadol have experience life-threatening respiratory depression and even death. The new warning further limits the agency's previous restriction of codeine use in children younger than age 18.

FDA announced Thursday that it is restricting the use of codeine and tramadol medicines in children.

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Codeine is a narcotic painkiller and cough suppressant with similar effects to morphine and hydrocodone, which are strong opioid medication. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. There are serious risks associated with the drugs, including slowed or hard breathing and death, which appear to be a greater risk in children younger than aged 12 years.

In a related safety memo, the FDA explained that all manufacturers of codeine and tramadol would be required to add several new warnings to their labels. Codeine labeling already warns against post-surgical use for kids. For children ages 12-18, and for breastfeeding mothers, the FDA said, the use of these medications should be limited. Besides a change saying that the drugs shouldn't be used in children under 12, the mandated changes include a new warning for tramadol saying it shouldn't be used in children younger than 18 for post-surgical pain after the removal of tonsils and adenoids.

"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said. It also identified three deaths and six other cases of serious breathing problems reported between January 1969 and March 2016 in children taking tramadol.

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At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them".

For more on opioid medications in pediatrics, visit the Boston Children's Hospital. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.

Parents should also discuss alternative pain medications for their kids with their doctors, as well as effective cough and cold remedies that do not contain opioids, the FDA said.

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