Federal regulators have approved a kid-sized version of popular painkiller OxyContin, just as prescription drug abuse is becoming a big issue in the presidential race.
The Food and Drug Administration said Thursday that it approved the use of Purdue Pharma’s OxyContin in certain kids 11 years and older. Unlike prescriptions for adults, a child can only get the painkiller if they have already taken an opioid.
“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,” said Sheron Hertz, director of Anesthesia, Analgesia and Addiction Products for the FDA.
Hertz said on the agency’s website that children aren’t treated with opioids very often, and that the drug is usually reserved for children in severe pain. She said using long-acting opioids means fewer daily doses and could free up patients for physical therapy appointments or allow them to go home from the hospital earlier.
Purdue agreed to study the effects of the drug in children per the FDA’s request.
Hertz said that the warnings and precautions for children are the same as those for adults. She said parents and patients should discuss the benefits and risks of using the powerful painkiller.
OxyContin will become the second long-acting opioid approved for children, Hertz said. The other is a pain patch called Duragesic and manufactured by Johnson & Johnson.
OxyContin is one of the few painkillers that have features that prevent it from being snorted or injected, popular methods used by addicts to get a quicker high. But there is no protection for using the drug orally, another popular method, experts have said.
The Centers for Disease Control and Prevention estimates that each day 46 Americans die from a painkiller overdose.
The approval comes as prescription drug abuse is rising as a prominent issue among voters. A recent poll from Granite State and WMUR of New Hampshire voters found that drug abuse was the second biggest problem facing the state after the economy.
Democratic front-runner Hillary Clinton addressed prescription drug abuse earlier this week while campaigning in the state that will hold the first presidential primary.
“I did not expect that I would hear about drug abuse and substance abuse and other challenges everywhere I went,” she said, according to a report from the Wall Street Journal.
It remains unclear how the decision will play in Congress, which has previously criticized FDA approvals before. Back in 2013, lawmakers blasted the agency for approving a new long-acting opioid called Zohydro without abuse-deterrent features.
