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FDA Issues Multiple Restrictions on Codeine, Tramadol Use

21 April 2017

On Thursday, FDA said that some children are at higher risk of harm from the medicines because they break down codeine and tramadol more rapidly than normal, which can cause dangerously high levels of the drugs in the blood.

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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. "They can cause a lot of harm when they're not", said the FDA's Dr.

Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.

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In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially unsafe spike in the level of active opioids in the bloodstream. Between January 1969 and March 2016, there were nine cases of breathing problems including three deaths, involving the use of tramadol in children younger than 18.

Most of those cases occurred in children under 12, and some happened after just one dose of the medicine. The agency also found, in a review of the medical literature, a report of an infant who died after being exposed to codeine while breast-feeding.

Some children and adults are genetically predisposed to process opioid drugs more quickly, the FDA said.

The agency in 2013 had warned against use of codeine and tramadol in children and adolescents to treat pain after surgery to remove tonsils.

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"Today's actions build on a better understanding of this very serious safety issue, based on the latest evidence", Throckmorton said.

The agency on Thursday ordered several alternations in labels to underscore the risks of the drugs to children.

Almost 1.9 million kids aged 18 or younger received a prescription for a codeine-containing medication in 2014, and almost 167,000 were prescribed a medication containing tramadol, the FDA said. Tramadol will now also carry a similar warning label. The FDA urged parents to carefully read labels of nonprescription cough medicines to avoid codeine and to consult a doctor or pharmacist if needed.

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FDA Issues Multiple Restrictions on Codeine, Tramadol Use