Many patients may not realize they are being prescribed drugs “off-label” by their physician, according to an analysis by the Mayo Clinic. Off-label means a doctor prescribed a medication for treatment of a condition that has not been approved by the Food and Drug Administration for that particular purpose.
“Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” says Christopher Wittich, MD, an internal medicine physician at Mayo Clinic, who wrote a recent article about the practice in Mayo Clinic Proceedings. “Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one.”
A 2006 study found that 1 out of 5 prescriptions for commonly used medications were prescribed off-label. Another study found that nearly 80% of the children discharged from pediatric hospitals were taking at least one medication off-label. Many inhaled bronchodilators, anti-microbials, anti-convulsants and proton pump inhibitors are given to children without formal FDA approval.
Doctors are not required to tell patients that the medications they’re receiving are being prescribed off-label, but pharmaceutical companies can face severe penalties for encouraging physicians to prescribe drugs for conditions not approved by the FDA.
Merck was recently fined $322 million for illegally promoting the pain reliever Vioxx to treat rheumatoid arthritis. Merck’s fine is part of a $1 billion settlement announced last year in which the company pleaded guilty to off-label promotion. Merck sales representatives also made false statements about the cardiovascular safety of Vioxx, which was removed from the market after it was found to increase the risk of heart attack and stroke.
Last year Johnson & Johnson paid over $2 billion in fines for the illegal off-label marketing of Risperdal, an anti-psychotic medication, to nursing homes.
Off-label prescribing can be beneficial. Naltrexone, a drug used for decades to treat opioid addiction, has recently been found to be effective in treating fibromyalgia. FDA approval of naltrexone for fibromyalgia is unlikely, however, according to a Stanford University researcher studying the drug.
“The reason why that’s never going to happen for naltrexone is that it’s already generic, so there’s no financial incentive for any pharmaceutical company to go through that multi-million dollar process to get FDA approval,” said Jarred Younger, PhD, in an interview with American News Report . “This (naltrexone) will always be off label. That doesn’t mean anything’s wrong. Many drugs are given off label. It just means it won’t have that ultimate stamp of approval for that reason.”
Experts urge patients to ask their doctor when a prescription is written if the drug has been approved by the FDA to treat their condition. If the answer is “no,” they should ask their doctor why he thinks it will work better than a drug that’s already been approved for their condition.