The US Food and Drug Administration has announced on Thursday, Aug. 13 the approval of the limited administration of OxyContin for children aged 11 years old and above. According to the agency, the frequently abused and powerful pain reliever may now be administered in some medical cases that warrant it.
Opioids are strong painkillers that can help alleviate pain if appropriately prescribed and administered. OxyContin is manufactured by pharmaceutical company Purdue Pharma of Stamford in Connecticut and is an extended-release type of the opioid medication called oxycodone. Other opioids that come in oral preparations are also available in extended-release versions.
In a conversation released online at the FDA website, the Center for Drug Evaluation and Research (CDER) of the agency asks Dr. Sharon Hertz, director of new anesthesia, analgesia and addiction products for the FDA, various details regarding the approval of OxyContin for kids as young as 11 years old. According to her, Purdue was able to come up with a new indication of OxyContin for pediatric patients and has even provided healthcare professionals useful data regarding the appropriate prescription and administration of the drug in children.
Children are not usually prescribed with opioids; hence, Hertz said their team needed to meticulously identify the manner in which this medication is being used, as well as helpful information for prescribers.
In the study, OxyContin were administered in children at a time where prolonged need for opioids is anticipated such as after a significant trauma or during the postoperative phase of major surgeries involving the spine or correction of birth defects. This is because not many children suffer from the chronic pain of adult diseases. In the end, the study was able to fully support the indication of OxyContin in children aged 11-16 years old and even provided additional and specific information regarding the correct prescription of the drug in the said age group.
So, does this mean that OxyContin may be given to pediatric patients routinely in hospitals?
According to Hertz, OxyContin may be prescribed in patients, who require continuous opioid treatment even after discharge following trauma, surgeries and other similar cases. Their parents and caregivers should be educated and given adequate information regarding the drug to ensure that it is administered according to the recommended measures.
"We are always concerned about the safety of our children, particularly when they are ill and require medications and when they are in pain," says Hertz. Although OxyContin is not the first choice of opioid drug for pediatric patients, the research was able to supply data showing that it can be administered safely if correct strategies are applied.
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