Stretching uses of prescription drugs

Some researchers worry about doctors giving medications for `off-label' ailments

May 19, 2006|By LOS ANGELES TIMES

Millions of Americans are prescribed drugs each year that are not approved for their specific medical condition, a practice known as "off-label" use, that is legal and logical in many cases.

But a new study has found that 20 percent of all prescriptions are written for non-approved off-label uses and that most of these uses - three-quarters - are not well-supported by scientific research.

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 Boston's 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 their patient interactions during 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 also 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 percent 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 in Palo Alto, Calif., said the findings were troubling. Even though drugs are thoroughly reviewed by the Food and Drug Administration before they are 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 trials - but those data may be irrelevant when a medication is used for a different diagnosis and in different patients.

Off-label use of drugs is not rare. Once a drug reaches the market, doctors can legally prescribe it for any diagnosis. This long-standing practice has been lauded for allowing doctors the freedom to treat their patients based on the latest scientific studies and clinical information.

In certain areas of medicine, such as pediatrics, off-label use of medications is almost unavoidable because, until recently, drug manufacturers were not required to conduct research on how their products affect children. And in cancer treatment, off-label use allows doctors to try different strategies for seriously ill patients who have exhausted other options.

Off-label use also makes sense when the drug is prescribed for a condition very similar to its approved indication. For example, Stafford says, doctors can reasonably assume that a drug used to treat asthma will be effective for other lung diseases.

"There are plenty of situations where off-label use is completely legitimate," Stafford says. "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."

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