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(Ivanhoe Newswire) -- When your doctor prescribes a medication, you just assume its been fully vetted by the U.S. Food and Drug Administration (FDA).
Thats not true in all cases. The FDA approves prescription drugs for specific uses. However, doctors have the right to prescribe that same drug for any use they deem appropriate. Statistics suggest off-label prescribing is not an isolated incidence, but happens in up to 50 percent of all prescriptions currently written in the United States.
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Whats more, pharmaceutical companies may be covertly promoting the off-label use of their products to increase sales. Researchers from Washington, DC, and California suggest pharmaceutical marketing has distorted the discourse on off-label uses and encouraged the unmonitored, potentially dangerous use of drugs by patients for whom risks and benefits are unknown.
Fellow researchers from the University of California Davis (UC-Davis) argue doctors have an obligation to let their patients know when they are receiving a drug that hasnt been approved for their specific ailment so doctor and patient can discuss the risks and benefits of the treatment. This is particularly important when it comes to children, because off-label use is common in the pediatric population, where many drugs havent been specifically tested.
The UC-Davis investigators call for open, honest discussion where doctors tell their patients that the use of the drug will be off-label and thus not approved for this indication, explain the risks, potential benefits, and alternatives, and then ask patients for their permission to proceed.
SOURCE: PLoS Medicine, published online November 10, 2008
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