FDA Approves OxyContin for Children 11 and Older

The Food and Drug Administration has approved limited use of the powerful and frequently abused painkiller OxyContin for children as young as 11 years old, the agency announced Thursday.


However, this medicine hasn’t been approved for use in children before.

OxyContin machine Purdue Pharma LP, that were inquired through FDA to assess the medication’s use in boys and girls, may also run postmarketing clinical trials.

Under the new approval, doctors are directed to only prescribe OxyContin to children who can already tolerate a minimum dose of 20 milligrams of oxycodone, the drug ingredient in OxyContin.

The only opioid approved for use among children is the Duragesic pach, which releases fetanyl. Without such a tolerance, taking a sudden dose of an opioid can result in overdose and death, according to the AP.

Hertz was quoted as saying that part of the reasoning behind the decision to allow OxyContin prescriptions is that no real painkilling solutions exist for children or teens who need “daily, round-the-clock” pain relief over a long period of time.

Purdue Pharma, reporter Erin Shumaker pointed out, saw three of its executives plead guilty in 2007 to misleading doctors and regulators about the drug’s addiction risk.

The FDA said Purdue must conduct a follow-up study to examine the rates of injury, overdose, accidents and medication errors in children taking the drug, with the report due in April 2019.

According to the Associated Press, the study involves prescribing the medicine to child patients that are expected to require the use of opioids in managing pain for many weeks.

The long-acting drug already treats adults suffering from around-the-clock pain, and has been reformulated over the years to combat rising prescription drug abuse in the United States.


“This way, the doctor knows that their patient tolerates and responds appropriately to opioids and knows the amount of opioid treatment needed to manage the patient’s pain”, she adds. The powerful painkiller, manufactured to relieve the pain of seriously ill people, is being used by some addicts to achieve a high similar to a heroin rush.

US clears opioid OxyContin for 11-16 year olds