Why might a physician prescribe a drug for off-label use?
1. The mechanism of action of the drug might suggest that it would be beneficial to a patient who is not responding to other treatment options. 2. Individual studies or case reports may suggest benefit for other indications when there is preclinical or laboratory studies that suggest an existing drug might have benefit in FA. However, pre-clinical or laboratory studies that suggest potential benefit of a drug rarely translates to benefit in patients. The cellular and animal models used in laboratory testing have limitations and do not closely replicate the human disease. Also, the experience with many disorders has shown that drug candidates identified in laboratory studies usually do not show the same benefit when delivered to patients. Off-label use impact on clinical trials? When a physician is prescribing a drug to treat a patient, this is not considered research or a study this is medical management and decisions made are solely between the patient and the physician. Patients shou
