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FDA sends warning letter to Novo Nordisk over failure to report deaths, adverse side effects of GLP-1s
The FDA cited unreported serious events, including three deaths and suicidal ideation, revealing Novo Nordisk's lapses in post-marketing adverse drug experience reporting.
- The FDA's March 5 warning letter to Novo Nordisk, pharmaceutical company, requested details on steps taken to comply with PADE reporting after failures to report semaglutide side effects.
- An inspection in last year at Novo Nordisk's U.S. headquarters in Plainsboro, New Jersey, was conducted as part of the Bioresearch Monitoring Program, FDA investigators found problems.
- The FDA cited three deaths among patients receiving semaglutide, including one suicide, and noted a patient reporting suicidal ideation, but the agency did not assert the medications caused the deaths.
- The FDA gave Novo Nordisk two weeks to outline corrective actions, and the company said on Tuesday it has been 'working diligently' since last year's inspection, with Anna Windle pledging to address requests expeditiously.
- The FDA's monitoring program depends on complete ADE submissions, with January's boxed-warning removal request framing the March 5 letter amid ongoing oversight.
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FDA Warns GLP-1 Maker Over Failure to Properly Report Deaths, Strokes
(MedPage Today) -- The FDA issued a warning letter to Novo Nordisk for failing to report and investigate potentially serious side effects associated with its popular GLP-1 medications. In a letter dated March 5 and made public on Tuesday, the...
·New York, United States
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Total News Sources28
Leaning Left4Leaning Right0Center21Last UpdatedBias Distribution84% Center
Bias Distribution
- 84% of the sources are Center
84% Center
L 16%
C 84%
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