Why the FDA Approved Oxycontin for Kids

fda-approves-child-oxycontin

The answer is pretty simple. The FDA approved Oxycontin because in extreme cases where children may have cancer or need some sort of long-term pain relief, Oxycontin is one of the best pain relieving medications out there.

Take Lynn Brown’s daughter Amanda for example. In 1999 she was diagnosed with a childhood form of brain cancer, she endured multiple surgeries, weeks of radiation, months of chemotherapy and numerous blood transfusions—not to mention pain.

Doctors prescribed her morphine and when that became less effective over time, they switched to, what was new at the time, Oxycontin. Doctors eventually weaned Amanda off the narcotic after several months. Now 32, she survived her cancer, graduated from college and just recently got married.

And her story is the kind of story that the FDA was thinking of when it approved the Oxycontin, an extended release form of the painkiller oxycodone, for children as young as 11 who need daily long term pain relief that can’t be treated with other medications.

The Approval of Oxycontin for Children

The decision to approve the drug was welcomed by some pediatricians and pain specialists, but it also caused uproar. On social media, people accused the FDA of acting irresponsibly and putting the interests of the manufacturer’s, Purdue Pharmaceuticals, ahead of the children who they were worried would become addicted to it.

The FDA defended its decision saying that the idea was not to expand the use of opioids for children as whole but rather to give doctors better guidelines about how to use Oxycontin safely in pediatric patients. Doctors can already prescribe the medications any way they see fit and many physicians have long given Oxycontin and other potent painkillers to children suffering from cancer, major surgeries or other trauma.

Prior to the approval, the FDA asked Purdue to conduct studies checking the safety and effectiveness of Oxycontin in pediatric patients. FDA officials said the results supported the use of the drug in limited situations such as when pain couldn’t be treated effectively with a less powerful drug.

“We understand there is a terrible problem with opioid abuse and addiction,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “But this is about evidence-based medicine for children — seriously ill children who are suffering pain.”

The Problem with Kids Taking Oxycontin

But this kind of reasoning hasn’t calmed down those who are concerned. For instance, Andrew Koldny, a New York psychiatrist and direct of Physicians for Responsible Opioid Prescribing.

He says the agency failed to sufficiently weigh the risk of addiction, which is greater in children whose brains aren’t fully developed yet. And he says the new approval of the drug will lead to Purdue, marketing it more broadly.

“You’re talking about a privately held company where executives have faced criminal charges for the way they marketed OxyContin,” he said. “You’re giving a company with a very bad track record permission to market this drug for children. I think they’re going to take advantage of that.”

Koldny also said the FDA should have convened a public advisory committee hearing to consider the issue, considering the given crisis involving the abuse of prescription painkillers going on in the country right now. He said there are rare circumstances when giving this type of drug to children is necessary but he said the FDA’s decision does nothing to expand access to those patients, given that doctors could already prescribe the drug in those situations.

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