Your 12-year-old with ADHD is often wired late into the night and has problems sleeping. So his doctor prescribes Clonidine, which is approved by the FDA to treat hypertension, but is often used to treat ADHD-related insomnia, sleep apnea, alcohol and drug withdrawal, and Tourette’s syndrome—it’s just not approved by the FDA for those conditions.
So why is your child’s doctor prescribing it? “It’s an example of off-label use of a prescription drug,” says Richard Morel, MD, an internist at WESTMED Medical Group. Though off-label prescribing is a common practice—about one in five prescriptions are written for off-label uses, according to a 2012 Consumer Reports article—and though it is legal (“once you have a license to practice medicine, you can prescribe any medication for anything you want,” says Dr. Morel), an off-label indication may or may not be good for what ails you.
“The FDA will certify a drug for approved use,” says Dr. Morel. “Pharmaceutical companies are not allowed to promote off-label uses. They’ve gotten in trouble for that.” Trouble is an understatement. In 2012, GlaxoSmithKline agreed to plead guilty to two counts of introducing misbranded drugs and to pay $3 billion—the largest sum ever paid by a drug company. The drugs in question: Wellbutrin and Paxil. Though Paxil was never approved by the FDA for treating depression in kids, GSK unlawfully promoted the drug for that use. It also promoted the antidepressant Wellbutrin for weight loss, treatment of ADHD and sexual dysfunction, and substance addiction.
Still, Dr. Morel says, there are many examples of off-label prescriptions that are accepted as standard of care. “Take aspirin,” he says. “It is standard of care for all diabetics because of its cardio-protective effects. In fact, Medicare has it as a quality metric for diabetes care. Yet it is not FDA-approved for that indication.”
It is important for physicians to know the standard of care before prescribing off-label. A responsible doctor will not prescribe a medication for an off-label use unless he or she is certain that there are studies backing up its benefits and clinical data to support its use.
“One example of bad off-label prescribing is the use of anti-psychotics like Seroquel and Haldol for Alzheimer’s disease,” says Dr. Morel. “There’s no clinical data to show there’s any benefit.”
In addition, says Dr. Morel, “some of the anti-psychotics, such as Seroquel, are used for sleep, an off-label use that I’m not comfortable with.” The drug, he explains, “can cause weight gain and diabetes; anti-psychotics are serious medicine, and there should be placebo-controlled studies to demonstrate efficacy.”