FDA Warns Novo Nordisk Broke Safety Reporting Rules

Source: US News & World Report

“Federal regulators have warned the maker of Ozempic and Wegovy that it failed to report possible drug side effects to the government. In a March 5 warning letter, the U.S. Food and Drug Administration (FDA) said Novo Nordisk committed ‘serious violations’ related to safety reporting for semaglutide, the active ingredient in both medications, NBC News reported. The FDA said the company did not report several serious adverse events, including three deaths among patients taking the drugs, by the legal deadline. One of the deaths involved a patient who died by suicide, according to the agency. The FDA also said the company failed to investigate or report that case properly. The agency stressed that the letter does not mean the medications caused the deaths or other side effects.” (03/12/26)

https://www.usnews.com/news/health-news/articles/2026-03-12/fda-warns-novo-nordisk-broke-safety-reporting-rules