In clinical trials of a thousand adults with obesity or overweight, 3% of those treated with 2.4 mg of Wegovy (2,116 people) reported hair loss compared to 1% of those in the placebo group (1,261 people)
Sources of evidence included the submitted De Novo request document and the corresponding FDA De Novo classification decisions (FDA Evaluation of Automatic Class III Designation De Novo Summaries), as well as the principal US federal laws (1938-2023) and the FDA regulations and guidance (19762023) relating to medical devices, including the (1) Food, Drug, and Cosmetic Act of 1938, (2) Radiation Control for Health an Safety Act of 1968, (3) Medical Device Amendments of 1976, (4) Safe Medical Devices Act of 1990, (5) FDA Modernization Act of 1997, (6) Medical Device User Fee and Modernization Act of 2002, (7) FDA Amendments Act of 2007, (8) FDA Safety and Innovation Act of 2012, (9) 21st Century Cures Act of 2016, and (10) FDA Reauthorization Act of 2017
FDA is cracking down on off-brand weight loss and diabetes drugs (CNN) The crackdown on off-brand weight loss and diabetes treatment drugs is about to take effect, meaning supplies for the treatments are likely to tighten
Other plans require prior authorization, documented failed attempts with older medications, or a BMI above 30 with obesity-related complications before approving coverage
It acts as a stimulant for your body, increasing your energy levels without causing the jitters or crash that come with caffeine or other stimulants
Hatsell, S
