Millions of Americans each year are prescribed drugs that are not approved for their specific medical condition, a practice that is legal and logical in many cases. But a new study has found that fully 20% of all prescriptions are written for such nonapproved uses and that most of these -- three-quarters -- are not well-supported by scientific studies.
This widespread use of medications "off-label" could threaten patients' safety while escaping the attention of federal regulators, some experts suggest.
"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," says Kenneth I. Kaitin, director of the Tufts Center for the Study of Drug Development. "It's an issue that should be discussed in the medical community." Still, Kaitin says, it's unclear whether consumers are being put at undue risk. "There has not been a significant problem with off-label prescribing that I'm aware of," he says.
The study, published last week in the Archives of Internal Medicine, polled 3,500 randomly selected doctors on all of their patient interactions over two consecutive days in 2001, including any drugs they may have prescribed. Researchers then retrieved information on the 100 most commonly prescribed drugs as well as 60 more drugs that were randomly selected.
Among other things, the scientists found that cardiac medications, anticonvulsants and asthma medications were the most likely to be prescribed off-label. Psychiatric drugs and allergy medications were the most likely types of drugs to be used off-label with little scientific support. In fact, scientific support was lacking for 96% of the psychiatric drugs prescribed off-label.
Dr. Randall S. Stafford, lead author of the study and an associate professor of medicine at the Stanford Prevention Research Center, said the findings were troubling. Even though drugs are thoroughly reviewed by the Food and Drug Administration before they're allowed to go to market, "the FDA does not vouch for the safety and efficacy of all the various ways that drugs are used," he says.
Drugs, he adds, are tested and approved at specific doses with detailed information about side effects that occurred during the trials -- but those data may be irrelevant when a medication is used for a different diagnosis and in different types of patients.
