FDA Approves OxyContin For Extremely Sick Kids

15 Aug

The U.S. Food and Drug Association approved the painkiller OxyContin for children ages 11 to 16 with pain “severe enough to require daily, around-the-clock, long-term opioid treatment,” according to a statement released on Aug. 14.

Some experts expressed concern that the approval might lead to drug misuse among children or their family members, who may have access to the drugs. But doctors who treat dying children and those in chronic pain say that the move will be a boon to many of their patients. 

“Although thankfully uncommon, some children can experience prolonged periods of substantial chronic pain from conditions like cancer,” said Dr. Chris Feudtner, director of the Department of Medical Ethics at the Children’s Hospital of Philadelphia, who has no connection to the drug.

“For these patients, strong pain medications can offer tremendous relief,” he said. 

OxyContin, the extended time-release version of the generic narcotic oxycodone, has been all over the news in recent years for its role in the public health crisis of opioid addiction. Experts blame the rise of prescription painkiller use in the United States for the nation’s current heroin epidemic. As it stands, four out of five new heroin users abused prescription painkillers first, according to the Center for Behavioral Health Statistics and Quality.

Although OxyContin, is just one of many painkillers on the market, it took particular criticism because representatives promised officials and doctors that the drug was safe and effective for patients with chronic pain. In actuality, its time-release formula made it more likely to result in abuse

OxyContin is made by Purdu Pharma, a drug company with a tarnished reputation after three of the company’s top executives pleaded guilty to misleading doctors, regulators and the public about OxyContin’s addiction risk in 2007. The company agreed to pay $600 million in fines. Following the trial, the FDA banned the original OxyContin formula and in 2010, the company developed an uncrushable tablet that was more difficult to snort or inject than the original. 

But despite OxyContin’s rocky track record among adults, doctors who treat extremely sick children note that these powerful drugs aren’t as likely to result in abuse.

“Children rarely get ‘hooked’ on these medications the way that adults can,” Feudtner said, noting that all strong pain medications have the potential be misused by friends or family members of the patient.

It’s a question of “actively managing and monitoring the use of these medications,” Feudtner said. “So that children in need get what they need and everyone stays as safe as possible.” 

“Everybody gets all excited about OxyContin, but we forget that there are a large number of children and adolescents who suffer from chronic pain,” said Dr. Lonnie Zeltzer, a professor of pediatrics and the director of the Mattel Children’s Hospital’s Pediatric Pain and Palliative Care Program at UCLA. 

Zeltzer, an outside scientist who was a paid committee member of the data safety and monitoring board that oversaw the Purdu trials, said that she’s long been a proponent of encouraging companies to do studies of drugs like OxyContin on children.

“They are being used anyway, but without the data,” she said, noting that doctors and pediatricians will prescribe off-label drugs to chronically ill children, or children in palliative care, if they don’t have other options. “There was so little that was evaluated in children that physicians were using medication that wasn’t studied,” she said.

And as for the risk of opioid abuse by friends of family members, Zeltzer doesn’t think kids should suffer for adults’ mistakes. “Diverted use in adults doesn’t mean that children should be deprived of the proper studies and safety parameters.”