oral semaglutide before and after The Pros Cons of for Weight Loss FDA Approves Oral Semaglutide for

& Masson, P

1 Introduction Obesity, as an identified chronic disease, has become a severe public health challenge worldwide

doi: 10.1056/NEJMp1314078 78 Bjerre KnudsenLMadsenLWAndersenSAlmholtKde BoerASDruckerDJet al

Pool of Placebo- and Active-Controlled Trials The occurrence of adverse reactions was also evaluated in a larger pool of adult patients with type 2 diabetes mellitus participating in 9 placebo- and active-controlled trials [see Clinical Studies (14)]

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While safety within the phase 3 program is sufficient for marketing authorization (although the risk of cardiovascular events should not exceed a hazard ratio of 1.8 according to a guidance document that was released by the FDA at that time), it is the post-marketing phase in which rare adverse events and any other potential safety risks are identified or resolved