OxyContin Approved for Kids, Worrying Doctors

I don’t know who thought this was a brilliant idea …. it sure wasn’t me. There is already a lack of education from our physicians and too many commercials promoting drugs and individuals with substance abuse problems. My issue is with the article states “After a week on these drugs, the body becomes physically dependent on them. And along with dependence, patients develop a tolerance, so they need higher and higher doses to achieve the same effect, he said. … The brain does not fully mature until age 25, and there is good evidence that people who begin using drugs before that age are more likely to develop an addiction”. Click here to read the full article or an excerpt below.

Perhaps the biggest concern with OxyContin, and opioid painkillers in general, is the risk of addiction.

After a week on these drugs, the body becomes physically dependent on them, Kolodny said. And along with dependence, patients develop a tolerance, so they need higher and higher doses to achieve the same effect, he said.

Although it’s hard to say how often children who take OxyContin will develop an addiction, the brain of an adolescent is more susceptible to becoming addicted to drugs, Kolodny said.

The brain does not fully mature until age 25, and there is good evidence that people who begin using drugs before that age are more likely to develop an addiction, he said.

Approval issues

One reason the FDA approval has made doctors uncomfortable is that they fear patients will think that doctors support the drug’s use in children with chronic pain, Harrison said.

“It sends mixed messages to the public,” she said. And patients may ask for the drug more directly, she said.

Indeed, the majority of medications that are prescribed to children are given off-label, Kolodny said. Other drugs, such as Percocet and Vicodin, are also given off-label to children, he said.

“The fact that OxyContin didn’t have the indication for the use in children didn’t stop doctors,” he said. But now that OxyContin is approved — while other painkillers still aren’t — people will be more likely to want to use OxyContin, Kolodny said.

Especially with the recent attention given to the United States’ opioid-addiction epidemic, it seems puzzling to some that the FDA approved OxyContin for adolescent use.

“The main concern I have about the FDA’s decision is that they bypassed the advisory committee,” Kolodny said. According to the agency’s website, the FDA brings in an independent scientific-advisory committee of experts when an approval decision may be of significant public interest or controversial, or may require special expertise.

“I very strongly believe that had they brought it before a scientific advisory committee” that included addiction specialists and neurobiologists, it would not have been approved, Kolodny told Live Science.

Live Science reached out the FDA for a comment on its decision to forego an advisory committee. FDA press officer Eric J. Pahon said, in part, “We are experienced in reviewing applications for pediatric uses. We can and do take issues to advisory committees when we need to. In this case, given our experience in reviewing these applications and given the data presented, we concluded that an advisory committee was not needed.”

“To avoid an inefficient use of resources, we take pediatric applications to an advisory committee only when scientific issues arise that require the input of a committee. Pediatric studies are discussed by the FDA extensively prior to initiation by sponsors,” Pahon told Live Science in an email.

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