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Prescribing drugs `off-label' routine but can harm patients.

Knight Ridder/Tribune News Service

| November 01, 2003 | Young, Alison; Adams, Chris | COPYRIGHT 2003 Knight-Ridder/Tribune News Service. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

Byline: Alison Young and Chris Adams

WASHINGTON _ Patients nationwide are being injured and killed because doctors routinely are prescribing drugs in ways never certified safe or effective by the Food and Drug Administration, a six-month Knight Ridder investigation has found.

Over the last year, 115 million such prescriptions were written, nearly double the number of five years ago, the newspapers' analysis of prescriptions for a sample of top-selling drugs found.

The investigation discovered that the practice, called off-label prescribing, is often driven by questionable research, aggressive drug-company marketing and cavalier doctors, and condoned by tepid regulators.

"Sometimes it may help, sometimes it may do more harm than good and sometimes it may kill people," said Dr. Arnold Relman, a former editor of the prestigious New England Journal of Medicine.

Knight Ridder reviewed 15 top-selling classes of drugs and found that some, such as cholesterol medicines, rarely are used as unapproved treatments. But three-quarters of anti-seizure medications are prescribed off-label for such things as depression and hot flashes and to help people lose weight. Nearly two-thirds of antipsychotics were prescribed off-label, including for insomnia and attention deficit disorder. And about one-quarter of the prescriptions for antidepressants were ...

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