Health Care

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

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.

The FDA plans to hold a public advisory committee meeting later this year to discuss the broader use of prescription opioid cough and cold medicine in children, he said.

Douglas Throckmorton, a top official at the FDA's Center for Drug Evaluation and Research, said in telephone briefing for reporters that the safety hazards are the result of the "unique way" these medications are broken down in the bodies of some children and adults.

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. It also identified three deaths and six other cases of serious breathing problems reported between January 1969 and March 2016 in children taking tramadol. The FDA also warned breast-feeding mothers to avoid using the medicines while nursing their babies.

In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.

Birth Control Pills Affect Women's Well-Being
Since the changes were relatively small, the results must be interpreted with a certain amount of caution, researchers said. The Swedish researchers wanted to test this hypothesis and see how birth control pills might impact a woman's life.

"The science is clear, so why did it take nearly 18 months since the FDA's public meeting on the exact same issue?"

Tramadol is a prescription drug that is only approved for adults to treat pain, the agency noted. 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. Another new warning to codeine and tramadol labels recommends against their use in adolescents between 12 and 18 who are obese or have other conditions that might affect their breathing, such as lung disease or sleep apnea. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children previous year. The FDA said it is requiring makers of prescription versions of the medicines, codeine and tramadol, to change the products' labels to warn against giving them to children under age 12, and to limit use in older children.

In addition, labeling for tramadol-containing products will get a contraindication for post-operative pain management in children up to age 18 years of age who have undergone the removal of the tonsils and/or adenoids, which is already in labeling for codeine products.

Parents should carefully read drug labels to make sure medications don't contain either opioid, the agency stressed.


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