FDA Approves Opioids For Some Children- Pain News

The U.S. Food and Drug Administration has approved OxyContin for children between 11 and 16 years old with severe pain.

“We requested the manufacturer of the pain management drug OxyContin (Purdue Pharmaceuticals) perform studies evaluating safety and other important information about oxycodone and OxyContin when used in pediatric patients. These studies supported a new pediatric indication for OxyContin in patients 11 to 16 years old, and provided prescribers with helpful information about the use of OxyContin in pediatric patients,” Sharon Hertz, MD, director, Division of Anesthesia, Analgesia, and Addiction Products, Office of New Drugs, at the Center for Drug Evaluation and Research (CDER), said on the FDA website.

The drugs would be given to children with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA notes that the same health warnings that apply to adults apply to children taking OxyContin. Doctors should not combine the drug with any other medications that can add to its sedating effects, which could lead to breathing difficulty.

Unlike adults, pediatric patients must already be responding to and tolerating a minimum opioid dose equal to at least 20 mg of oxycodone per day for 5 consecutive days before they can be prescribed an equivalent dose of OxyContin, Dr. Hertz said.

The FDA mentions severe pain caused by trauma, surgery or cancer as potential uses for opioids in children. OxyContin is a long-release version of oxycodone, an opioid that acts on the brain like heroin and is intended for only the most severe and chronic pain cases.

The FDA says it is putting strict limitation on the use of OxyContin in children. Unlike adults, children must already have shown that they can handle the drug by tolerating a minimum dose equal to 20 milligrams of oxycodone for five consecutive days, she said. The FDA notes that the Duragesic patch is the only other opioid approved for children.

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