Maker of Ozempic, Wegovy Failed to Report Strokes, Suicidal Ideation and Deaths

by Brenda Baletti, Ph.D.

The maker of several blockbuster weight-loss drugs failed to report serious side effects, including strokes, suicidal ideation and deaths, according to the U.S. Food and Drug Administration (FDA).

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…

 

READ FULL ARTICLE HERE… (childrenshealthdefense.org)

 

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