A new study published in JAMA Internal Medicine suggests that using drugs “off-label” can increase the risk of side effects, particularly when there is little data to support an unapproved indication. When a medication is prescribed off-label, it is being used in a manner not approved by the U.S. Food and Drug Administration (FDA). Physicians are allowed to prescribe drugs off-label, and often do so. Pharmaceutical companies, on the other hand, cannot promote their products off-label. A number of personal injury lawsuits stem from allegations that a drug maker marketed a products for a use not approved by the FDA.
The study was conducted by a Canadian-US research team, who analyzed data on about 46,000 adult patients receiving over 151,000 prescriptions from primary care clinics in Quebec from 2005 through 2009. Findings showed that patients were 54 percent more likely to experience an adverse event when using a drug off-label without strong scientific evidence. An adverse event may include a drug reaction, drug interaction or allergic response, US News Health reports.
Dr. Tewodros Eguale, who led a research team at McGill University in Montreal, said “We are not saying that off-label is bad,” according to US News Health. “But when it’s off-label and there’s no strong scientific evidence, we showed that there’s a high risk of adverse drug events.” Dr. Eguale said that if off-label use is being implemented, it should be discussed between patients and doctors.
The study found that the antidepressant trazodone (Oleptro), which is commonly used off-label for insomnia, is linked to hallucinations. Zyprexa is a schizophrenia drug frequently prescribed off-label for depression; researchers linked the drug to weight gain.
There are many instances where a physician has good reason to prescribe a drug off-label. It may be a last resort in a dire situation, or other treatments may not be an option. Dr. Randall Stafford, director of the Program on Prevention Outcomes and Practices at Stanford University in Palo Alto, Calif. said “Off-label use is higher than it should be, in part because the FDA does less than physicians and the public thinks it does,”
Eguale said strong evidence is lacking for off-label uses of the antipsychotic drugs quetiapine (Seroquel), risperidone (Risperdal) and Zyprexa. Quinine, a drug approved for malaria, is commonly prescribed for leg cramps and restless leg syndrome; due to the risk of serious bleeding, regulators have warned against its off-label use. “It’s not the biggest offender [in terms of adverse events], but its off-label prescribing rate is very high. Close to 99.4 percent of the time, it’s used for an off-label condition,” said Eguale.