Last August, the Food and Drug Administration caused an uproar when it approved the use of the narcotic painkiller OxyContin for some children.
OxyContin is a very powerful painkiller that is often linked to addiction. In 2014, a reported 1.9 million American suffered from a substance use disorder involving prescription painkillers. Many people who disagreed with the FDA’s decision worried that the not fully developed brains of children may be more susceptible to addition, essentially creating a government sanctioned jumpstart on painkiller addictions.
The drug is only approved for use in certain pediatric patients 11 years and older and only for limited situations like severe pain from cancer, surgery, or trauma that cannot be treated with other painkillers. Many parents who watched their children suffer debilitating pain from serious pediatric illnesses approved the legalization of the drug.
The FDA’s approval was not unprecedented; OxyContin was already being prescribed off-label to children, many who are younger than 11. Physicians treating pediatric patients with high levels of pain had few other drug options, and would prescribe the drug relying only on their personal experience to create age limits and dosage amounts.
According to the Harvard Petrie-Flom Center, 50% of drugs prescribed to children in hospitals are prescribed off-label, and about 80% of children in pediatric hospitals receive at least one non-approved off-label drug. The FDA’s approval for the use of OxyContin in children will clearly not be the first time it is prescribed to children, but the drug’s approval will allow for more regulations on its usage and increased research into its effects.
The FDA hopes that the drug’s approval will reign in the unregulated usage of the drug in children of all ages and at untested dosages.
Off-label prescriptions do not always equal malpractice. Drug regulations often lag behind discoveries of new treatments; many times off-label drugs are used in cutting edge, state-of-the-art treatments. Sometimes, a doctor prescribing an off-label drug to a patient shows that the doctor is providing the best possible care.
But off-label prescribing does come with risks and increased liability for the physician. Drugs that are approved for use by the FDA go through rigorous testing, which includes determining proper dosage and documenting effects. Doctors using drugs on unregulated patients, like children, do not have this research to reference.
The approval of OxyContin has caused a lot of anger in part because of the history of Perdue, the company that manufactures the drug. The company has faced criminal charges in the past for misleading regulators, doctors, and patients about OxyContin’s high risk of addiction.
Currently, there are no programs in place for children who suffer from addiction to the drug.
Parents of children receiving off-label drugs should not be afraid to ask their physicians about why their child is receiving the drug and what benefits that drug has over other alternatives. Off-label prescriptions can be an effective way to manage your child’s health condition, but some may come at the higher cost of your child’s overall wellbeing.