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Diabetes 50 , 227232 (2001)

The primary safety concern with compounded lipotropic preparations is variability in formulation quality and sterility , as compounding pharmacies operate under different regulatory standards than pharmaceutical manufacturers

An earlier Phase II trial11 and two essentially identical Phase III trials (a study of at least moderate size that compares a new treatment with the current standard of care in patients), Gout 1 and Gout 2 have been presented.13 Data on shrinkage of tophi with this agent was also presented in 6/09.13 Cardiac events have occurred during the studies of Krystexxa, and the FDA reviewed them closely and concluded that they did not appear due to the medication

For example: White tablets may be overlooked when they are laid out on a white tray, and so care must be taken to ensure that none has been missed

Following the recommended escalation schedule of at least 4 weeks per dose level minimizes discomfort