FDA further restricts pain medication use in kids

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. 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 Dr. Douglas Throckmorton, the FDA's deputy center director for regulatory programs, in a written statement. For children 12 years of age and in adolescents 18 years old (especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems), clinicians should recommend over-the-counter (OTC) or other FDA-approved medications for cough and pain management.

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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". Tramadol will now also bear this warning in addition to the other new contraindications and warnings. That can cause the level of narcotics in their bloodstream to rise too high and too quickly, risking overdose, the agency explained. They include the FDA's strongest warning, a "contraindication", specifying that tramadol should not be used in children who have had their tonsils removed.

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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 unsafe to youth between 12 and 18. 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.

"These medicines should also be limited in some older 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.

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A review of medical literature for data regarding the use of codeine in nursing mothers found several cases of excess sleepiness and serious breathing problems in breastfed infants, including 1 reported death.

Moreover, in order to counter pain and coughing, parents are advised to discuss alternative pain medications for their children with their doctors.

Codeine and tramadol are opioid medications used to treat pain. They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol.

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For more on opioid medications in pediatrics, visit the Boston Children's Hospital.

  • Jermaine Castillo