Friday, 22 September, 2017

FDA further restricts pain medication use in kids

FDA further restricts pain medication use in kids FDA further restricts pain medication use in kids
Ron Matthews | 22 April, 2017, 00:41

This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Codeine is used to treat mild to moderate pain and to reduce coughing. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk.

Douglas Throckmorton, a top official at the FDA's Center for Drug Evaluation and Research, said in telephone briefing for reporters that the safety hazards are the result of the "unique way" these medications are broken down in the bodies of some children and adults.

"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.

The agency noted that since 2013, prescription products containing codeine have contained a boxed warning and contraindication for children and teens up to age 18 for pain management after removal of tonsils and adenoids.

In the body, opioid painkillers and cough medicines are broken down into morphine. 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.

The US Food and Drug Administration (FDA) on Thursday announced label changes to two opioids, codeine and tramadol (found in various prescription pain and cough medicines and some over-the-counter cough medicines), to better protect children from serious risks. Apparently, narcotics such as codeine and tramadol can be fatal when used by children.

Codeine and tramadol medicines will now carry a "Contraindication" in children under 12 years old, which is the strongest drug warning label the FDA can add.

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".

"Our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe", Dr. Throckmorton said.

"These medicines should also be limited in some older children".

Numerous products containing these drugs are only available by prescription, but several over-the-counter cough medicines contain codeine.

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".

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