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It is a little absurd to blame animal safety data for hazards encountered from off-label prescribing.
A physician is free to use a medical device for an off-label purpose, if, in the physician's medical judgment, he or she believes that use of the device will benefit the patient.
Potentially fatal toxicities occur with off-label use of cancer drugs.
Although off-label prescribing is legal, the US Food and Drug Administration prohibits drug companies from promoting such use to doctors.
This issue affects all doctors and off-label drugs will be needed more often for very ill children reflecting the higher usage in hospital.
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