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FDA staff stated the compound lacks sufficient information to know whether the drug would cause harm when administered to humans. The committees public docket drew approximately 1,860 comments before the July 23-24 hearing, reflecting broad interest from patients, clinicians, and compounding pharmacists

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Most palpitations are benign sinus tachycardia or occasional premature atrial contractions caused by vagal modulation and electrolyte shifts, not structural cardiac abnormalities