fda import alert semaglutide tirzepatide green list September 8, 2025: launches an listing safe GLP-1 manufacturers – Partnership for Safe Medicines FDA creates "green list" to
Description
Data presented are for the efficacy estimand unless otherwise noted AHI apneahypopnea index (measured by polysomnography and reported in events per hour of sleep), CV cardiovascular, HF heart failure, HFpEF heart failure with preserved ejection fraction, hsCRP high-sensitivity C-reactive protein, KCCQ-CSS Kansas City Cardiomyopathy Questionnaire clinical summary score (range of 0100, with higher numbers indicating better quality of life), MASH metabolic dysfunctionassociated steatohepatitis, NASH nonalcoholic steatohepatitis, OSA obstructive sleep apnea, PAP positive airway pressure, SASHB sleep apnea-specific hypoxic burden, SBP systolic blood pressure, T2D type 2 diabetes Table 4
Heres a look at the typical pathway: Starting dose: 2.5 mg weekly (weeks 1 through 4) Dose escalation: Increase as needed and tolerated: 5 mg weekly 7.5 mg weekly 10 mg weekly* 12.5 mg weekly 15 mg weekly Maintenance dose: Any dose can be used for maintenance if it works for you

Infections: vulvovaginal candidiasis, bacterial vaginosis, vulvovaginitis Comparative observational signal (protective association): In a phenome-wide association study comparing people with type 2 diabetes prescribed GLP-1 receptor agonists vs SGLT2 inhibitors and DPP4 inhibitors (NIH All of Us cohort, Jan 2018Oct 2023), semaglutide prescription was associated with reduced risk of diagnoses including candidiasis of vulva and vagina and inflammatory disease of cervix, vagina, and vulva compared with SGLT2 inhibitors
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