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Important Warnings and Precautions Black Box Warning: Thyroid Tumors Ozempic has been associated with an increased risk of thyroid C-cell tumors in animal studies
One in-trial AE type was chosen (GI events) and tested both for treatment-dependent and treatment-independent linear and non-linear effects of age on AE incidence
Context: Thus, the prohibitions set forth in ANVISAs (Brazilian FDA) Rule #67/2007 , which governs Good Manufacturing Practices for Compounding Pharmacies, should also be applicable to these clinics. Decisions to make: timeline to implement vs transition window. Next steps: run a focused gap assessment
This article examines what constitutes a microdose, the rationale behind this approach, and the important safety considerations patients should discuss with their healthcare provider
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