Health
A Blockbuster Drug Faces Growing FDA Scrutiny Over Unreported Risks
Health Points
- The letter cited three unreported deaths, including a suicide, but did not claim causation.
- Novo Nordisk must respond within two weeks on corrective actions.
- The company affirmed it takes post-approval safety reporting seriously.
The FDA sent a warning letter to Novo Nordisk, maker of Ozempic and Wegovy, for delays in reporting potential side effects from these popular semaglutide medications.
Inspectors found serious violations after reviewing a New Jersey facility last year.
“FDA relies on the complete, accurate, and timely submission of ADEs to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health,” the agency stated.
“Novo Nordisk takes PADE reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” the firm stated.
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