The Los Angeles Times on Monday examined how the "widespread use" of medications prescribed for off-label uses -- those not approved by FDA -- could "threaten patients' safety while escaping the attention of federal regulators." According to a recent Archives of Internal Medicine study, medications prescribed for off-label uses account for about 20% of all prescriptions, and about three-fourths of those uses are not supported by scientific evidence. Randall Stafford, lead author of the study and an associate professor of medicine at the Stanford Prevention Research Center, said, "There are plenty of situations where off-label use is completely legitimate," adding, "But there are other ways that drugs are used that are quite distinct from the FDA indication and where we don't have good information." In addition, Stafford said that FDA is less likely to detect safety problems with medications prescribed for off-label uses than those prescribed for approved uses. Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said, "What surprised me about this study is that in many cases there is a paucity of scientific studies supporting the drug's use off-label." However, he added, "There has not been a significant problem with off-label prescribing that I'm aware of" (Roan, Los Angeles Times, 5/15).

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