The Food and Drug Administration’s decision last August to officially approve use and set guidelines for the use of Oxycontin, for certain children as young as 11 has triggered a huge debate among lawmakers, health care professionals, and parents about whether or not the drug is appropriate for treating pain in people under the age of 18.
The new guidelines do not “legalize” Oxycontin, per se – prescription opiates have been prescribed for years off-label – but this is the first time there have been recommended guidelines for doctors to prescribe the powerful drug to children suffering from certain conditions that cause chronic pain.
Some elected officials, as well as candidates running for office including Hillary Clinton, have echoed sentiments of addiction specialists who say the new guidelines will encourage doctors to expand access to a drug at the center of an epidemic of opiate abuse in the U.S. that was responsible for over 24,000 overdose deaths in 2013. They say health care providers need to focus on alternative pain management rather than relying on such an addictive drug to help their young patients.
Unfortunately, many physicians and families are pleased that the FDA has chosen to provide guidelines to doctors treating children with serious, debilitating and sometimes fatal conditions. Opiates are strong painkillers that can alleviate suffering of children with terminal conditions and rare musculoskeletal disorders.
Previously, doctors have had to rely on adult dosing information when prescribing the painkiller to children off-label, which are unsuited to young, very sick kids. The new guidelines help doctors safely administer the controversial drug and prevent accidental overdoses in youngsters.
The FDA says that the intent of the guidelines is to provide safe and reliable information, not expand availability or increase the use of the drug in children. The federal agency approved the drug for treating children ages 11-17 that suffer from severe, long-term pain, such as terminal diseases like cancer or kids recovering from severe automobile accidents. Many children in this age group have already been taking an opioid painkiller to help them cope with their health problems, and the guidelines set standards and dosages for safety purposes.
In addition to giving guidelines for the prescription, the FDA is requiring the drug’s manufacturer, Purdue Pharma LP, to conduct more studies on the drug’s use in children, and to report and keep track of all adverse events connected to the drug’s use in children.
Lawmakers, however, are not convinced that the benefits of the drug’s use in minors outweighs the risk, especially in states where opiate abuse has run rampant in recent years. Some elected officials in states grappling with rampant painkiller abuse are furious. “When we make it easier for kids to get this stuff, we are sentencing ourselves to more opiate addiction and more misery for America,” Gov. Peter Shumlin of Vermont told the Wall Street Journal.