On Thursday, the U.S. Food and Drug Administration (FDA) approved the painkiller OxyContin for use in children ages 11 to 16. The National Institute on Drug Abuse has previously stated that prescription opioids like OxyContin are “addictive” and could lead to heroin use. What could possibly go wrong?
In an Q&A with the Center for Drug Evaluation and Research (CDER), FDA official Sharon Hertz said the agency asked the manufacturer Purdue Pharma to study the use of OxyContin for pediatric patients under the Best Pharmaceuticals for Children Act of 2002, which offers patent exclusivity extensions to incentivize the study of medication for children.
After reviewing the results of a study in which OxyContin was prescribed to pediatric patients who had suffered from “extensive trauma” or who were recovering from “major surgery,” the FDA decided to approve the use of the medication with a special guideline for patients 11 to 16 years old: They must be able to tolerate a dose equivalent to 20 mg of immediate-release oxycodone per day before taking the extended-release OxyContin.
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Some physicians have prescribed OxyContin “off-label” to patients in this age group but now the medication will come with a specific “pediatric indication” from the FDA.
OxyContin is a powerful prescription opioid that essentially blocks pain receptors in the central nervous system. Because OxyContin is an extended-release form of oxycodone, it requires fewer and less frequent doses to effectively manage pain—a function that Hertz sees as “useful” for its new pediatric use.
“Fewer daily doses may free patients for physical therapy appointments, allow them to go home from the hospital sooner, and may help them to sleep through the night without waking up from pain,” she said.
But when taken recreationally to produce a high, prescription opioids can be dangerous and sometimes deadly.
Prior to the new OxyContin guidance, Duragesic—a form of fentanyl—was the only extended-release opioid specifically approved for pediatric use by the FDA. Fentanyl has recently come under fire in Canada, where the drug has contributed to at least 655 deaths between 2009 and 2014, according to a report from the Canadian Centre on Substance Abuse.
An official from the Canadian Pharmacists Association called fentanyl-related deaths “a disaster that’s happening right across Canada.”
In the United States, opioid painkillers contributed to nearly 17,000 deaths in 2011, a threefold increase from 2001, with young men much more likely than young women to overdose. If large enough, a single dose can cause serious breathing problems and even death.
For this reason, Hertz warned that parents and caregivers should “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.”
The FDA approval for OxyContin in younger patients comes at a moment when the use of the drug in teens was beginning to decline. In the early 2000s, as NPR reports, the percentage of 12th-graders who reported having used OxyContin in the last year was slowly climbing.
Now, according to a 2014 study funded by the National Institute on Drug Abuse (NIDA) and conducted by the University of Michigan, only 1 percent of 8th-graders and about 3 percent of 12th-graders have used OxyContin in the last year, with both figures at their lowest recorded points since 2011.
NIDA did not comment directly on the new OxyContin guidance but strongly reiterated the need to monitor any patient who receives prescription opioids.
Dr. Jack Stein, director of the Office of Science Policy and Communications at NIDA, told The Daily Beast, “Patients of any age who are candidates for treatment with opioid-based medications should be regularly evaluated for risk of addiction, educated about these risks, and carefully monitored for the duration of treatment.”
Daily Beast contributor and pediatrician Russell Saunders said that he supports the FDA’s decision “on balance” because OxyContin will be “immensely valuable” for those pediatric patients who need it.
“That being said, there is ample evidence of many powerful medications with significant side effects being prescribed carelessly by providers, including stimulants for ADHD or antipsychotics for behavior disorders,” he added. “Those who would prescribe OxyContin must do so with due caution and awareness for its potential for abuse, addiction, and diversion.”
There is also mounting evidence that the abuse of prescription opioids can lead to heroin addiction. A July study from the U.S. Centers for Disease Control and Prevention (CDC) concluded: “[T]he strongest risk factor for a heroin use disorder is a prescription opioid use disorder.”
An emerging heroin epidemic in the United States has not substantially impacted youngsters ages 12 to 17, with under 2 per 1,000 using the drug in the early 2000s and mid 2010s. But among older teenagers and young adults ages 18 to 25, heroin use has more than doubled from 3.5 per 1,000 in 2002-2004 to 7.3 per 1,000 in 2011-2013.
According to data from the National Survey on Drug Use and Health, youngsters ages 12 to 17 still perceive heroin as a high-risk drug but over 10 percent report “easy availability.”
In a statement on its website, Purdue Pharma notes that it has taken steps to address opioid abuse in the last several years, including funding addiction hotlines and working with law enforcement. The manufacturer also altered the OxyContin pill itself in 2010, making it more difficult to crush and dissolve for snorting and injection.
In an additional statement to The Daily Beast, Dr. Gail Cawkwell, Chief Medical Officer for Purdue Pharma, made it clear that OxyContin will not be specifically promoted for pediatric use: “While this new safety information will not be commercially promoted, its inclusion in the product’s full prescribing information is intended to better inform prescribers about safe and effective use of OxyContin.”
