On Thursday, the FDA said it will require that prescription drugs containing codeine or tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. The drugs can reportedly cause life-threatening breathing problems.
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. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol. In 2013, the agency restricted use of codeine in children to treat pain after surgery to have tonsils and adenoids removed. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe", said Douglas Throckmorton, MD, deputy center director for regulatory programs, Center for Drug Evaluation and Research.
Codeine and tramadol are opioid medications used to treat pain. The FDA also says breastfeeding women shouldn't take them because of possible harm to the baby. Codeine also is used in cough syrup and cold remedies and sometimes is combined with other medications, such as acetaminophen.
In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation. A change in the label is important, but unfortunately many doctors and patients don't read these labels. Tramadol is not approved for any uses in children, but it is commonly prescribed off-label to children anyway.
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Warning labels on medications with codeine or tramadol will be strengthened to reflect these potential dangers, the FDA said in a statement. Some people convert opioids into morphine very quickly, causing dangerously high levels of morphine in their body.
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. After several deaths were reported, the American Academy of Pediatrics warned parents against giving codeine to children past year.
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.
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