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"Off-label" Drug Prescribing Can Place Patients at Risk

Nov 4, 2015

"Off-label" drug use-when a doctor prescribes a drug for a use not approved by the Food and Drug Administration (FDA)-can put the patient at risk for serious side effects, a new study finds.

Physicians may legally prescribe any FDA-approved drug for any use they deem appropriate and doctors are not required to document the reason for prescribing a treatment, HealthDay reports.

But in an extensive review of the practice, a Canadian-U.S. research team found reason for concern. Patients prescribed off-label drugs without strong scientific evidence were 54 percent more likely to experience an adverse event-a drug reaction, drug interaction or allergic response-that forces them to stop taking the drugs, the study found.

Doctors have many reasons for prescribing off-label. The medications available to treat a condition may be limited; the patient may have exhausted the drug options; or medicines with good evidence of safety and effectiveness may not have gone through the FDA process. Dr. Randall Stafford, director of the Program on Prevention Outcomes and Practices at Stanford University, 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." Stafford said the FDA judges a drug's safety and effectiveness for a single clinical condition, but many physicians think of FDA approval as "a blanket endorsement," and this may lead to the use of drugs for clinical conditions that have not been evaluated."

For the study, published online in the journal JAMA Internal Medicine, the researchers examined electronic health record data for about 46,000 adult patients who received more than 151,000 prescriptions from primary care clinics in Quebec from 2005 through 2009. On that particular system, physicians using must enter the reason for each new prescription, change in dosage, or discontinuation, HealthDay reports. They must also include details of any adverse drug events. More than one in 10 prescriptions in the study were for an off-label use. Of those, the researchers said, more than 80 percent were for uses lacking strong scientific evidence.

The study authors identified 3,484 adverse drug events, though they acknowledged that the study might not have captured all medication-related events, according to HealthDay. Doctors can miss symptoms and patients may fail to mention all of their symptoms. The average cost per adverse event, considering possible emergency room visits and hospitalizations, ranges from $759 to $1,214, the authors estimated.

Dr. Tewodros Eguale, the lead researcher of a team at McGill University in Montreal said, "We are not saying that off-label is bad." But when there is no strong scientific evidence for a particular use, "we showed that there's a high risk of adverse drug events," he said.

Among drugs commonly prescribed off-label, the research team found that the antidepressant Oleptro (trazodone), often prescribed for insomnia, was linked to hallucinations. Weight gain was associated with the schizophrenia drug Zyprexa (olanzapine), which is often prescribed off-label for depression, HealthDay reports. The powerful antipsychotic drugs-Seroquel (quetiapine), Risperdal (risperidone), and Zyprexa-are prescribed off-label despite the lack of strong scientific evidence for those uses.

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