FDA okays OxyContin painkiller prescriptions for children as young as 11 years old

by Eric Pearson

The Food and Drug Administration has approved the use of the opioid painkiller OxyContin for children as young as 11 years old with severe pain that cannot be treated by other medications. Although doctors who treat children with cancer have praised the decision, other experts have expressed concern that prescribing OxyContin to children could increase their risk of addiction or other serious health consequences.

OxyContin is an extended-release version of the painkiller oxycodone, a drug which has been linked to a growing epidemic of opioid painkiller abuse in the U.S. Under the FDA’s new guidelines, the agency approved the use of OxyContin in patients 11 years or older who are already being treated with opioids, who can tolerate at least 20 milligrams of oxycodone per day, and who require “daily, round-the-clock, long-term” pain relief.

The FDA stated that its decision to approve OxyContin for use in children was influenced by the limited options for severe pain relief that younger patients have compared to adults. Although doctors have long prescribed opioid medications to patients with the approval of a parent or guardian, prior to the FDA’s recent approval decision, the only long-term opioid medication approved for use in children as young as 11 years old was Duragesic, a brand name version of the fentanyl pain patch.

As a result of this problem, the FDA asked Purdue Pharma, the manufacturer of OxyContin, to conduct safety studies to determine whether the drug could be safely prescribed to children ages 11-16 years old. The FDA has stated that despite the decision to approved OxyContin for use in children and teens, the agency will require Purdue to continue to submit safety data in the coming years to study how the drug is being prescribed to these younger patients.

Pediatric oncologists and other doctors who treat young patients with terminal illnesses praised the FDA’s decision, stating that it would allow them to concentrate on treating severe pain in young patients during end-of-life care. Because of the terminal nature of these young patients’ illnesses, the doctors stated, the risk of addiction associated with OxyContin was a less serious concern than managing the severe pain associated with cancer or other fatal diseases.

However, other health experts have cautioned that the FDA’s decision to approve the use of OxyContin for treating younger patients could make it easier for doctors to prescribe the drug to treat non-fatal illnesses. According to research presented in June 2015 at a meeting of the American Headache Society, one in six children who go to the doctor for migraines are prescribed prescription painkillers as a first-line treatment by their doctor. Health experts have warned that prescribing opioids to young patients in this fashion can cause their headaches to become more severe while also increasing the risk of dependency and addiction.

OxyContin and the Epidemic of Opioid Painkiller Abuse

Concerns about the use of opioid painkillers in young patients are especially troubling, these experts say, because of the alarming rise in opioid addiction in the U.S. According to the National Institutes of Health, more than 2.1 million Americans are struggling with opioid addiction, including many young people. Prescribing opioid to younger patients not only can increase their risk of becoming dependent or addicted to these medications, but can also increase their risk of heroin abuse. Health experts say that because the brains of teenagers and young children are still developing, they are at an even greater risk of addiction and abuse of opioid medications than adults who are prescribed these drugs. Studies have shown that about one in 25 high school seniors has abused OxyContin, a statistic cited by health experts who expressed concerns about the FDA’s recent decision to approve the drug for children.

Over the last two decades, the use of opioid painkillers in the U.S. has grown alarmingly. According to the Centers for Disease Control and Prevention, the number of opioid medications sold in the U.S. has quadrupled since 1999. Not surprisingly, the number of fatal overdoses from opioid painkillers has also risen alarmingly during this time. The CDC says that more than 44,000 Americans die from drug overdose each year, including 16,000 deaths from opioid painkillers.

This epidemic of opioid abuse and addictions has been fueled in part by the willingness of doctors to prescribe these medications to patients. Health experts say that many doctors prescribe opioids to their patients in cases where these drugs may not be necessary to treat pain. In other cases, opioid painkillers are prescribed in combination with other medications that can cause a drug interaction, leading to a risk of a combined drug overdose.

Recent lawsuits have also blamed the pharmaceutical industry for the rise in opioid painkiller overdoses. Purdue Pharma has faced several lawsuits over the company’s aggressive marketing of OxyContin, which state health officials have blamed for the alarming rise in cases of abuse, addiction, and overdose linked to the drug. Lawsuits filed against Purdue have accused the company of aggressively marketing OxyContin to doctors while downplaying the health risks associated with the drug.

Heygood, Orr & Pearson and Opioid Painkiller Lawsuits

The marketing of OxyContin and other opioid painkillers by Purdue and other drug companies has had a disastrous effect on the lives of patients who developed addictions or suffered overdoses caused by these medications. Doctors who indiscriminately prescribe these opioid medications to patients have also contributed to the growing epidemic of prescription painkiller overdoses in the U.S.

Patients who have suffered an overdose or who have become addicted to prescription painkillers may be eligible to file a lawsuit against the manufacturer of the medication they were given, as well as the doctor or hospital who prescribed the drug. The first step in filing a lawsuit is to secure the help of an experienced attorney who can help guide you through the process of filing a claim.

The lawyers at Heygood, Orr & Pearson have represented numerous individuals who have suffered overdose, addiction, or other complications from opioid painkiller prescriptions. Our law firm has handled more cases involving the fentanyl pain patch—a powerful painkiller about 80-100 times more powerful than morphine—than all other law firms in the country combined. Our firm has both the training and experience to prosecute medical malpractice cases involving a wide array of serious opioid painkillers, including Vicodin and hydrocodone, OxyContin and oxycodone, methadone, hydromorphone, and other medications.

If you or a loved one have suffered as a result of problems caused by opioid painkillers, contact the lawyers at Heygood, Orr & Pearson to learn more about filing a lawsuit. For a free legal consultation, please call toll-free at 1-877-446-9001 to speak with an attorney. You can also contact us following the link to our free case evaluation form and answering a few simple questions about your history to get started.

by Eric Pearson

Eric Pearson is a licensed attorney and a partner at HO&P who handles commercial and personal injury lawsuits. Eric has been selected to the Super Lawyers List, a Thomson Reuters publication.