FDA sends warning letter to Novo Nordisk over failure to report deaths, adverse side effects of GLP-1s

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Novo Nordisk regarding alleged failures to report adverse side effects, including patient deaths, associated with its GLP-1 medications, Ozempic and Wegovy. According to the FDA's March 5 letter, the agency identified "serious violations" of reporting requirements during an inspection. This action highlights regulatory scrutiny over pharmaceutical companies' compliance with safety reporting protocols. The warning could lead to further investigations or enforcement actions if the issues are not adequately addressed by Novo Nordisk. This situation underscores the FDA's role in ensuring drug safety and manufacturer accountability.