FDA further restricts pain medication use in kids

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.

The FDA also added a new "Warning" advising against the use of products with codeine and tramadol in children ages 12 to 18 who are obese or have obstructive sleep apnea or serious lung disease.

To view the full article, register now. Others might metabolize codeine or tramadol too quickly. Apparently, children's bodies break down such narcotics faster than adults do which results in a dangerously high level of drug in their bodies, hence it was concluded that codeine and tramadol can be fatal to kids.

On Thursday the FDA said it will require prescriptions that require codeine or tramadol to have a warning a label that warns against using them in children or women who are breast-feeding.

The US Food and Drug Administration warned the public on Thursday regarding the use of certain medications containing narcotics. Since 2013, prescription codeine labeling has contained a Boxed Warning and Contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils (tonsillectomy) and/or adenoids (adenoidectomy).


"These medicines should also be limited in some older children". If a codeine-or tramadol-containing product is determined to be appropriate for an adolescent patient, clinicians should provide counseling on how to recognize the signs of opioid toxicity.

The FDA labeled the drugs with their strongest warning, called the "contraindication", to alert consumers to always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. Between January 1969 and March 2016, there were nine cases of breathing problems including three deaths, involving the use of tramadol in children younger than 18. Presently, codeine is approved to treat pain and cough - including as a frequent ingredient in prescription cough syrups - and tramadol is approved to treat pain.

At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, "My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them". Finally, FDA is adding a strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants.

Aside from breathing issues, codeine also causes nausea, vomiting, abdominal pain, constipation, and skin allergies.


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