Home / Business and Economy / FDA Warns Novo Nordisk Over Ozempic Side Effect Reporting
FDA Warns Novo Nordisk Over Ozempic Side Effect Reporting
11 Mar
Summary
- FDA issued a warning letter to Novo Nordisk regarding Ozempic.
- Company failed to report all suspected patient side effects.
- More than 300 reports were significantly delayed or missing.
Novo Nordisk A/S has been issued a warning letter by the US Food and Drug Administration (FDA) due to concerns over the reporting of suspected side effects associated with its widely used diabetes medication, Ozempic. The FDA's March 5 letter highlighted instances where not all adverse events, including two deaths and a suicide, were appropriately reported.
The regulatory agency's inspection, conducted early last year, revealed over 300 reports that had not been submitted to the FDA, with some delays exceeding 1,000 days. Novo Nordisk acknowledged these reporting failures, which date back to 2020, and stated its commitment to address the FDA's concerns comprehensively and expeditiously.
The company indicated it has been collaborating with the FDA on an action plan since the inspection. Despite this, the FDA noted that Novo Nordisk has not yet demonstrated that its proposed changes will prevent future violations. This situation arises as Novo Nordisk competes in the significant US market for diabetes and obesity drugs.
