Senators Question FDA Approval of OxyContin for Kids

Last week without too much fanfare, the U.S. Food and Drug Administration (FDA) approved the narcotic painkiller OxyContin for pediatric use. A bipartisan group of Senators are now questioning that approval.

Maine Sen. Angus King, and New Hampshire Sens. Jeanne Shahaeen and Kelly Ayotte, are calling for an investigation into the FDA’s decision. They also asked in the letter to the Senate Health, Education, Labor and Pensions Committee on Wednesday for an investigation into the rise in opioid abuse and overdose deaths.

The Senators said the August decision to approve the use of OxyContin in pediatric patients is a step in the wrong direction and could lead to a rise in use among a population that is already at a higher risk for developing dependency and addiction. OxyContin is an extended-release version of oxycodone.

However, the FDA believes that the drug is safe for children as young as 11, and las limited it to those who are experiencing chronic pain that cannot be treated successfully with other medications.

According to an article in Newsweek, physicians have been prescribing OxyContin to children for some time but without the safety and efficacy data. The FDA does not regulate the practice of medicine, which means drugs such of OxyContin may be prescribed for off-label use to children once a caregiver has provided consent. An FDA representative stressed that the drug’s approval is not intended to expand or change the way it is used for pediatric patients.

Dr. Sharon Hertz, director of the division of anesthesia, analgesia and addiction products at the Office of New Drugs, part of the FDA’s Center for Drug Evaluation and Research, said “The major difference is that all pediatric patients that are considered for pain management with OxyContin should already have been treated with an opioid pain medicine. This way, their health care providers know that these pediatric patients can be treated safely with OxyContin.”

The approval is for children 11 and older who are already tolerating a minimum daily dose of at least 20 milligrams per day. The agency says that with extended-release OxyContin, a child may require two doses a day, versus four to six of the immediate-release version of the drug. The approval comes after Purdue Pharma, the drug’s manufacturer, submitted data to the agency that indicates the drug is safe for children if used correctly.

Hertz said prior to this review, physicians have had to rely on safety and efficacy data from studies of the drug in adults, and it was uncertain if this data is an accurate predictor of the effects the drug may have on children.

But the very fact that pediatricians are prescribing the drug to children is troubling to some experts, in addition to the Senators, since rates of opioid addiction are on the rise, especially in young people. According to the National Institutes of Health, approximately 2.1 million Americans are struggling with an addiction to prescription painkillers. Even worse, abusing this class of drugs is often a precursor to heroin addiction.

Pediatric specialists primarily prescribe opioids to children to manage chronic headaches and migraines, as well as for the treatment of musculoskeletal and abdominal pain. However, some experts argue that the specialists are too quick to prescribe these drugs to kids.

Research presented in June at the American Headache Society’s annual meeting finds that nearly 1 in 6 children who see a specialist for migraines are prescribed opioid medications as a first-line therapy, even though use of the drug can cause the condition to become more chronic and treatment-resistant and may increase the risk for drug addiction. (Purdue addressed potential abuse in 2010, when the company released a re-formation of the drug that is tamper-resistant and difficult to crush or dissolve.)

Hertz says OxyContin comes with the same level of risks for children as adults, as long as the drug is used under strict supervision by a physician and caregiver. She said it’s important for parents and physicians to make sure a child understands the potential risks that may arise from the drug and how to use it safely. Likewise, parents should be educated by health care professionals on what to watch out for, such as whether a child asks for more of the drug beyond the amount prescribed.

“Parents and caregivers should follow all the usual safeguards for storing powerful medications when OxyContin is in their home,” Hertz explained on the FDA website. “Briefly, make sure the medications are stored securely so young children never have direct access and also so that no one else in the household, such as older children, siblings, friends or other visitors, have direct access. Also, it is extremely important to safely and properly dispose of unused OxyContin as soon as it is no longer needed. As with all opioid drugs, OxyContin shouldn’t be kept casually in the bathroom medicine cabinet; it should always be secured.”

It remains to be seen if the Senate announcement will lead to any changes or if the FDA ruling will stand.

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Lindsey McCoyLindsey McCoy MPA, is an Executive Medical Recruiter and former Executive Director in the not for profit sector.

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