FDA further restricts pain medication use in kids


In addition, a new Warning is being added to the drug labels of codeine and tramadol to recommend against their use in adolescents between aged 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

The Food & Drug Administration began tracking reports of children suffering unsafe side effects from the pain meds codeine and tramadol in 1969, and now, almost 50 years later, the agency is finally taking tough action against the manufacturers of those medicines.

Codeine already carries a black-box warning, which the FDA added in 2013, stating that the medication should not be used to treat a child's pain after surgery to remove his or her tonsils.

The FDA is now advising health care professionals that the use of codeine or tramadol containing medicine is only FDA-approved for adult usage as it has proven to be fatal to kids.

Throckmorton said that the agency was both increasing restrictions on the products' labels and issuing a warning to consumers and pediatricians because of new information and concerns about the drugs' risks.

The FDA is reminding healthcare professionals that tramadol and single-ingredient codeine medications are only FDA-approved for adult use. 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.

The U.S. FDA is restricting the use of two narcotic analgesics - codeine and tramadol - since children experienced life-threatening respiratory depression and even death after their intake.

The FDA is now warning against children under 12 taking either codeine or tramadol. Tramadol will now also carry a similar warning label.

"These medications carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children", the FDA said in a statement released on Thursday.

"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 healthcare providers and parents", explained Throckmorton. However, please know that our decision today was made based on the latest evidence and with this goal in mind: "keeping our kids safe". They also can ask their doctor or pharmacist if a specific medication contains codeine or tramadol. Those infants can become too sleepy, have difficulty breastfeeding, or have serious breathing problems.

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

There are also alternative OTC and prescription medications available for cough.

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