The FDA reprimanded Novo Nordisk for “serious violations” in failing to report serious side effects tied to its blockbuster GLP-1 drugs, including Ozempic and Wegovy. Investigators said the company didn’t report cases involving strokes, suicidality and patient deaths, raising concerns about systemic problems in its drug safety monitoring.

The FDA this month issued a formal warning letter to Novo Nordisk, reprimanding the pharmaceutical giant for “serious violations” in failing to report serious side effects linked to Ozempic, Wegovy and Saxenda. The March 5 letter followed FDA inspections, conducted in January and February, of Novo Nordisk’s U.S. operations in Plainsboro, New Jersey.

Investigators concluded the company failed to comply with federal regulations governing the reporting of post-marketing adverse drug experiences (PADE) — a critical safety system used to detect safety signals after the drugs are already on the market.

https://childrenshealthdefense.org/defender/novo-nordisk-ozempic-wegovy-fda-warning-letter-fail-report-deaths-side-effects/?