FDA Approves OxyContin for Children 11 and Up

Photo Credit: Morguefile.com

Photo Credit: Morguefile.com

The Food and Drug Administration has approved limited use of OxyContin for pediatric patients as young as 11-years-old, on Thursday. The decision is a highly controversial one, considering the painkiller has been frequently abused.

THZ spoke with Board Certified Anesthesiologist, Dr. Nina Radcliff, on the matter.

“OxyContin is a narcotic. It’s considered long acting or extended release, meaning it lasts for several hours,” Dr. Radcliff said. “When you have pain, especially chronic pain, or pain that lasts for hours, you don’t want to take a medicine that you have to take every two to four hours. The medicine will wear off and then you start experiencing pain and then you take another dose of medication.”

Why such a strong drug for such young children?

Dr. Radcliff explained that the drug is not for all children. The FDA had a specific group of pediatric patients in mind.

“They want to introduce this to children who have special circumstances of pain: cancer, trauma, major surgery. Pain can be debilitating, it can be exhausting, it can cause difficulty with speech, it can make it difficult to concentrate, it can effect the child’s self-esteem, it can disable them, and it can make them isolated,” Dr. Radcliff said. “So, the concern is for children who have cancer or who are at the end of their life.”

In addition to the strength of the drug, the main concern is the possibility of addiction. Dr. Radcliff explained that children are more prone to addiction, since their brains are still developing, “We are concerned about children who are having acute pain, meaning pain for a short period of time. We do not want them to get addicted to this. Children who are younger, before their brain has developed, they are more likely to become addicted if they are exposed to it.”

Dr. Sharon Hertz, director of new anesthesia, analgesia, and addiction products for the FDA told NBC News that, unlike adults, children have already show that they can tolerate a minimum dose equal to 20 milligrams of oxycodone (OxyContin is the long-release version of oxycodone) for five consecutive days.

Though drug abuse remains a concern, the good news is that OxyContin was reformulated about 5 years ago to prevent patients from being able to crush up the pills for a high.

“There is some improvement in that, but we are always worried about the risk of addiction,” Dr. Radcliff said, referring to the reformulation of the drug. “More recently there’s about 44,000 people dying from drug overdoses every single year and prescription painkillers are increasing the number of people who are dying from that.”

OxyContin, according to Dr. Radcliff, when abused, can slow down the rate of breathing to the point where one can either pass out or go into a coma. When the breathing slows down, it eventually stops and there is no oxygen going to the brain, lungs, or heart, causing death.

Despite the downsides to the drug, it seems that this is the currently the best option in terms of helping pediatric patients suffering from chronic pain. The only other FDA approved option for children in need of a painkiller is the Duragesic patch, which releases fentanyl.

“We do not have good options. The only other option is the Duragesic, the name for fentanyl, which is a very strong painkiller,” Dr. Radcliffe said. “It’s applied as a patch on your skin that you usually have to switch every 72 hours. The concept is that it will last more than three days before you have to switch and take more medication. So, you’re not having that up and down.”

The main concern at this point, the drug being approved by the FDA, is how strictly it will be regulated. With all of the risks at hand, people are concerned about the way in which drugs will be monitored.

“The FDA did not create an advisory panel before approving this. It may be appropriate, but we always want to have input before making decisions,” Dr. Radcliff said. “I think before a controversial decision, you always want to have a panel to discuss the good and the bad.”

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