The FDA gives doctors that discretion as long as the off-label use seems reasonable.
There had been an expectation that the agency might try to limit off-label use.
Off-label use usually gets talked about when companies find way to encourage doctors to prescribe medicines inappropriately.
Dr. Yank and her colleagues used a database of hospitalizations to estimate national patterns of off-label use of the drug.
Punishing the off-label use of cognitive enhancers may also be unfair to those who find these drugs medically useful in unexpected ways.
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Would similar off-label use happen if Revimid were approved for another disease?
But off-label use is becoming increasingly common even where diseases aren't lethal.
But two studies released yesterday in the Annals of Internal Medicine found no evidence that the off-label use of the drug saves lives.
This includes, but is not limited to the current ongoing Medicare review of the product, which is probably aimed at limiting off-label use.
We have done a good job of cracking down on off-label use of many medicines, and on limiting the overselling of new drugs.
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Off-label use of NovoSeven has previously raised concerns, partly because a drug that promotes formation of clots can increase risk of heart attacks and strokes.
InterMune is far from alone in benefiting from such off-label use.
InterMune, however, is not betting everything on off-label use of Actimmune.
With any off-label use, there are concerns about safety and efficacy.
Case in point: two new reports looking at off-label use of the hemophilia drug NovoSeven and two soon-to-be-released studies comparing the off-label use of Avastin vs.
While the authors stress that there were limitations to their findings, they raise concerns that the off-label use of NovoSeven is both ineffective and less safe.
The new studies, being published Tuesday in the Annals of Internal Medicine, provide a detailedlook at the extent of off-label use and associated risks and benefits.
But some doctors are worried that harm will spill over to other patient groups, given the rampant off-label use of antipsychotics for treating ailments such as depression, Alzheimer's symptoms and anorexia.
"I think we made it very clear that none of us could support off-label use, " says Steven Nissen, head of cardiology at the Cleveland Clinic and a member of the panel.
Clyde Yancy, medical director of the heart and vascular institute at the Baylor College of Medicine, and another FDA panelist, notes that with drugs, so-called off-label use is often a scandal.
In an editorial accompanying the studies, Jerry Avorn and Aaron Kesselheim of Harvard Medical School and Brigham and Women's Hospital, Boston, questioned whether "improper" marketing may have contributed to the off-label use of NovoSeven.
Because making any promotional statement regarding the off-label use of a drug constituted, at the very least, a criminal misdemeanor offense, pharmaceutical companies spent millions of dollars annually on compliance and training programs to deter and detect off-label promotion by sales representatives.
And the drugmaker has consistently warned that off-label use can be perilous, pointing to reports of serious infections and blindness traced to contamination in vials during repackaging, an issue that temporarily led the US Department of Veterans Affairs suspend use ( look here).
Indeed, in the past, Pfizer (nyse: PFE - news - people ), the world's biggest drug company, owed much of the sales volume of its epilepsy medicine Neurontin to off-label use for pain and for disorders ranging from panic to bipolar disorder.
But doctors are allowed to use stents however they want, and 60% of the time they do so in ways the FDA hasn't recommended, a practice referred to as "off-label" use.
In February, when results in mice were published suggesting that a skin-cancer drug, bexarotene, was beneficial for Alzheimer's, many patients or their families started calling their doctors to ask whether they should use it off-label.
Jean Slutsky, director of the agency's Center for Outcomes and Effectiveness, said the research was undertaken because clinicians have indicated that uncertainly over the risks and benefits of NovoSeven for the off-label uses posed a dilemma on whether or how to use the drug.
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