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Off-label use of medicines is common. Because many off-label uses have not been carefully studied, it is important that postmarketing drug safety systems be able to identify, assess, and monitor adverse events that occur in the off-label setting. The full range of postmarketing surveillance and analysis tools can be utilized to study the adverse effects of medicines used off-label. Clinical Pharmacology & Therapeutics (2012); 91 5, 787–795. doi:10.1038/clpt.2012.24
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Gerald J. Dal Pan (2012) studied this question.
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