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FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

On April 20, the FDA issued a consumer alert warning parents that codeine and tramadol, which are both opioids, can cause risky breathing problems in children.

The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be risky to youth between 12 and 18.

The FDA has issued a drug safety communication regarding new restrictions for the use of codeine and tramadol medications in children and nursing mothers.

A 2012 review of pediatric deaths linked to codeine use resulted in an FDA boxed warning restricting its use in children younger than 18 years to treat pain after surgery to remove tonsils and adenoids. Codeine products are available by prescription, with some states allowing the drug to be sold over the counter.

Codeine is a narcotic painkiller and cough suppressant with similar effects to morphine and hydrocodone, which are strong opioid medication.

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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. Some children who have taken codeine or tramadol have suffered life-threatening breathing problems and in some cases.

In Thursday's announcement, the FDA said, "Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk". The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death. Codeine is often combined with acetaminophen in prescription pain medicines and cough syrups, the agency said. Tramadol will now also bear this warning in addition to the other new contraindications and warnings. 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. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

"We understand that there are limited options when it comes to treating pain or cough in children and that these changes may raise some questions for health care providers and parents", Throckmorton said. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids "are generally mild and go away in a few days, so they may not need to take any medicine".

Unlike adults, some children don't metabolize the drug, which prompts adults to give a higher dose in order for the medication to be effective.

Atlanta pediatrician Dr. Maia Walton said she rarely prescribes opioid pain medications to her patients.

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