Published: Sat, April 22, 2017
Health Care | By Kelly Miles

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids

US regulators are strengthening warnings about the dangers of two types of powerful opioid painkillers, codeine and tramadol, due to risks of slowed breathing and death.

The majority of serious side effects occurred in children younger than 12, sometimes after a single dose, the FDA said. In 2016, the FDA further investigated all reports of adverse events, including 24 deaths, linked to codeine-containing medicines in children younger than 18 years of age.

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In its statement, the FDA has rounded up a list of codeine-containing drugs to watch out for - such as codeine sulfate, codeine phosphate, Butalbital, Acetaminopen, Tylenol, Promethazine, Prometh VC, Triacin-C, Tuxarin ER, and Tuzistra-XR.

Read the label to make sure the medicine doesn't have codeine or tramadol. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially risky spike in the level of active opioids in the bloodstream.

Youths ages 12 through 18 who are obese or have obstructive sleep apnea (blocked airflow during sleep) or a weakened respiratory system shouldn't take codeine or tramadol.

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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 risky to youth between 12 and 18.

FILE - In this photo taken October 14, 2015, file photo, the Food & Drug Administration campus in Silver Spring, Md. 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". FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding women due to the possible risk to their babies. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. Tramadol is a prescription drug approved only for use in adults to treat moderate to moderately severe pain. We also encourage parents to review the ingredients of pain medicines to see whether they include codeine or tramadol, and cough medicines to see if they contain codeine.

Meanwhile, the FDA advises Clinicians to refer parents to seek over-the-counter products or possibly FDA-approved prescription medicines that are not fatal to kids under 12-years old.

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

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

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