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Kenneth McCall, published a paper in 2025 finding that compounded GLP-1s were linked to higher rates of adverse effects than non-compounded products between 2018 and 2024, including more abdominal pain, diarrhea, and nausea

The applicant added that the single serious adverse event observed during the study occurred in the standard of care reusable arm and that the authors noted that patients in the reusable cystoscope group reported significantly higher pain with urination post-procedure

Bovine collagen allergy

Its concentration decreases significantly with age, from approximately 200 ng/mL at age 20 to 80 ng/mL by age 60

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