More than one in seven common medications are prescribed for off-label uses that often lack adequate scientific support, according to a study published Tuesday in the Archives of Internal Medicine, USA Today reports. FDA approves medications for specific uses and for patients with specific conditions, but the agency does not regulate how physicians ultimately prescribe the medication, according to USA Today. For the study, researchers from the Stanford University School of Medicine and Dartmouth Medical School examined data from the 2001 IMS Health National Disease and Therapeutic Index to define prescribing patterns for 160 commonly prescribed drugs. Of the medications studied, researchers determined whether a prescription was for an approved or off-label use and assessed scientific evidence for off-label prescriptions (Rubin, USA Today, 5/9). The 160 drugs accounted for 725 million prescriptions in 2001, and of those, 151 million, or 21%, were prescribed off-label, the study finds. Seventy-three percent of those uses were not supported by adequate scientific evidence, according to the researchers. Cardiovascular, antiseizure and asthma medications were most likely to be prescribed for off-label uses (Corbett Dooren, Wall Street Journal, 5/9). Medications for diabetes blood sugar control, pain relief and high cholesterol were the least likely to be prescribed for off-label uses (USA Today, 5/9). The study authors said that off-label prescribing needs to be examined further to determine whether it "compromises patient safety or represents wasteful medication use." Lead author Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center, said, "We want to avoid the situation where a drug clearly has some risks associated with it but we are uncertain about its benefits." Edward Langston, a member of the board of trustees of the American Medical Association, said the organization "certainly supports off-label use, but based on sound scientific data. Otherwise, we have to be very cautious" (Adams, Philadelphia Inquirer, 5/9). An abstract of the study is available online. NPR's "All Things Considered" on Monday reported on the study. The segment includes comments from John Jenkins, director of the FDA Office of New Drugs; Peter Levine, an orthopedic surgeon in Bethesda, Md.; and Stafford (Silberner, "All Things Considered," NPR, 5/8).

The complete segment is available online in RealPlayer.

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