Off-Label Drug Use Raises Questions

<"">Off-label drug prescribing—using approved drugs for non-approved purposes—has long been an accepted part of the medical community. Now, a recent national survey is raising some questions regarding the safety and efficacy of such practices.

Science Daily reports that a number of physicians surveyed wrongly believed some off-label drug uses were approved by the U.S. Food and Drug Administration (FDA). This error in thinking could result in increased prescriptions for such uses even though there is insufficient data supporting many off-label uses, said Science Daily. The agency regulates marketing, not prescribing, of approved medications; physicians are free to prescribe medications as they see fit.

“Off-label prescribing is common, but researchers have not always known why. Our research shows that some off-label prescribing might be driven by mistaken beliefs about FDA approval and the level of evidence supporting off-label drug use,” said G. Caleb Alexander, MD, MS, Assistant Professor of Medicine at the University of Chicago Medical Center, quoted Science Daily. Dr. Alexander is a corresponding author of the research, which is to be published in Pharmacoepidemiology and Drug Safety.

“The results indicate an urgent need for more effective methods of informing physicians about the level of evidence supporting off-label drug use—especially for common off-label uses that are ineffective or carry unacceptable risks of harm,” Dr. Alexander added, according to Science Daily.

The survey found that physicians (599 primary care physicians and 600 psychiatrists) could not correctly state the FDA approval status of more than half the medications included in the survey. The incidence was often higher in those doctors who had prescribed off label, said Science Daily. The survey was conducted in 2007-2008 and included 22 drug-indication pairs that included an array of approval uses: On-label, off-label supported by medical evidence, and off-label deemed ineffective, all based on an “an independent drug compendium,” according to Science Daily.

In 2006, about 21 percent of all drug prescribing was found to occur off-label with most—73 percent—lacking scientific backing of the drug’s efficacy, said Science Daily, citing the Archives of Internal Medicine. Off-label prescribing occurs most frequently for anticonvulsants (74 percent), antipsychotics (60 percent), and antibiotics (41 percent), said Science Daily.

Off-label usage has been a source of controversy for some time. For instance, off-label drug promotion, which is illegal, made headlines when the United States Department of Justice (U.S. DOJ) announced that a drug company manager was being sentenced for off-label promotion of Bextra, a violation of the Food, Drug and Cosmetic Act. The FDA stated that the risks—a high rate of heart attacks, strokes, other cardiovascular injuries, and Stevens Johnson Syndrome—posed by Bextra outweighed its benefits.

The FDA approved Bextra, a Cox-II inhibitor, in November 2001 for the signs and symptoms of osteoarthritis and adult rheumatoid arthritis. In 2001, the FDA specifically denied Pfizer’s request to approve Bextra for acute pain, including surgical pain, because the safety in these other uses had not been established and it was specifically concerned about the results of a study in which there was an excess of cardiovascular events in patients who underwent coronary artery bypass graft surgery and used Bextra.

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