Weight-loss Drug Maker Failed To Report Strokes, Suicidal Thoughts and Deaths
The maker of fat-loss drug Wegovy / Ozempic failed to report serious side effects including strokes, suicidal thoughts and deaths to the Food and Drug Administration
TL;DR
- Novo Nordisk failed to report serious side effects, including strokes, suicidal thoughts, and deaths, associated with Wegovy, Ozempic, and Saxenda to the FDA.
- The FDA issued a formal warning letter to Novo Nordisk following inspections that revealed "serious violations" of reporting requirements.
- The company allegedly failed to investigate serious cases, including a disabling stroke and a patient suicide, with inadequate justifications.
- FDA inspectors discovered that Novo Nordisk's contractors continued to "inappropriately invalidate" cases of serious adverse events even after being warned.
- The FDA described these failures as "systemic failures" impacting the company's entire product portfolio.
- Recent attention has focused on the side effects of weight-loss drugs, with psychiatric issues, hormonal problems, and gastrointestinal issues being reported.
- Tens of thousands of people are currently suing manufacturers of these drugs for alleged physical damages.