FDA Decision to Approve OxyContin for Children as Young as 11 Stirs Debate

The Food and Drug Administration’s (FDA) decision last month to approve the opioid painkiller OxyContin for children as young as 11 has been welcomed by some pediatricians and pain specialists, The Washington Post reports. Some critics, however, say the decision could lead to increased abuse of the drug.

The FDA approved OxyContin for children as young as 11 who need “daily, round-the-clock, long-term” pain relief that cannot be adequately treated with other medications, the article notes. The FDA has said it does not intend to expand the use of opioids in children, but wants to give doctors better guidelines about how to use the drug safely in children.

Many doctors already prescribe OxyContin and other opioid painkillers “off label” to children with cancer, or who have undergone surgery or other trauma, the FDA noted. Once a drug is approved by the FDA, doctors can prescribe it “off label” to unapproved age groups or for unapproved conditions.

The FDA asked the maker of OxyContin, Purdue Pharma, to perform studies that evaluated the safety and effectiveness of the drug in children. FDA officials said the results supported the use of OxyContin in limited situations, such as pain that could not be effectively treated with other medications.

U.S. Senator Joe Manchin of West Virginia is a strong critic of the approval. He sent a letter to the Acting Commissioner of Food and Drugs at the FDA, Dr. Stephen Ostroff, condemning the decision. “This recent decision by the FDA to prescribe OxyContin to children as young as 11 years old is a horrifying example of the disconnect between the FDA approval process and the realities the deadly epidemic of prescription drug abuse are having on our communities,” he wrote.