Greater Risk of Side Effect with “Off-label” Drug Prescribing, Study Finds

When a drug is prescribed “off-label”—for a use not approved by the Food and Drug Administration—the patient can be at greater risk for serious side effects, a new study finds.

A Canadian-U.S. research team did an extensive review of off-label prescriptions and found that patients who were prescribed drugs off-label without strong scientific evidence were 54 percent more likely to experience a drug reaction, drug interaction or allergic response that forces them to stop taking the drugs, HealthDay reports.

Off-label prescribing is legal, though drug companies are prohibited from promoting their drugs for anything other than approved uses. A physician may legally prescribe an approved drug for any use he or she deems appropriate for the patient. Doctors are not required to document the reason for prescribing a particular drug, according to HealthDay.

Doctors have many reasons for off-label prescribing. The medications available to treat a condition may be limited and a patient may have exhausted the drug options. Medicines with good evidence of safety and effectiveness may not have gone through the FDA approval process. Dr. Randall Stafford, who directs 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. Many physicians think FDA approval is “a blanket endorsement,” and this can lead to drugs being prescribed for clinical conditions for which they have not been evaluated.

For the study, published online this week in JAMA Internal Medicine, the researchers examined electronic health records for approximately 46,000 adults in Quebec who received more than 151,000 prescriptions from primary care clinics from 2005 through 2009. In the record system examined, physicians must enter the reason for a new prescription, a change in dosage, or discontinuation of a medicine, HealthDay explains. The record must also include any adverse drug events. According to the study, more than one in 10 prescriptions were for an off-label use, and more than 80 percent were for uses lacking strong scientific evidence, the researchers said.

The research team 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 or patients may not mention all of their symptoms to the doctor. Including possible emergency room visits and hospitalizations, the authors estimate that the average cost per adverse event ranges from $759 to $1,214.

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

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

 

 

 

from Parker Waichman http://www.yourlawyer.com/blog/greater-risk-of-side-effect-with-off-label-drug-prescribing-study-finds/