What it does mean is that the warning language that drove millions of women away from a potentially beneficial treatment for over two decades has now been formally revised - following the FDA's own comprehensive review of the evidence that supported the November 2025 announcement
Benefits include: \Weight Loss: Mean 15.2% body weight reduction
B12 injection is generally safe with minimal side effects
Insurance providers and PBMs negotiate with each other, manufacturers, the government, and individual pharmacy chains to determine pricing and coverage
Cardiovascular outcomes: Does the triple mechanism provide CV benefits beyond weight loss
Treatment of patients with decompensated cirrhosis, defined as one or more of the clinical complications of chronic liver disease ascites, encephalopathy, variceal bleeding, and/or impaired hepatic synthetic function is more problematic