Additional Coverage:
FDA Issues Stern Warning to Ozempic and Wegovy Maker Novo Nordisk Over Unreported Side Effects
The Food and Drug Administration (FDA) has delivered a serious warning to pharmaceutical giant Novo Nordisk, the company behind the popular medications Ozempic and Wegovy. The FDA’s reprimand stems from the company’s alleged failure to promptly report potential side effects experienced by patients taking its blockbuster drugs.
In a strongly worded letter dated March 5, the FDA accused Novo Nordisk of “serious violations” regarding the reporting of adverse drug events linked to semaglutide, the active ingredient found in both Ozempic and Wegovy.
The agency specifically highlighted three patient deaths among those using the medications, including one case of suicide, which the FDA claims were not reported within the mandated timeframe. Furthermore, the FDA stated that Novo Nordisk failed to adequately investigate or report the suicide. It’s important to note that the FDA did not explicitly state that the medications caused these deaths or other reported side effects.
“FDA relies on the complete, accurate, and timely submission of ADEs [adverse drug events] to monitor a product’s safety profile and uphold FDA’s mission to protect and promote public health,” the FDA emphasized in its letter.
These findings reportedly emerged from an inspection conducted last year at a Novo Nordisk facility located in New Jersey.
The FDA has given Novo Nordisk a two-week window to outline the steps it plans to take to prevent future reporting violations.
In response, Novo Nordisk issued an online statement asserting that it has been working “diligently” to address the FDA’s concerns. “Novo Nordisk takes PADE [post-approval adverse drug experience] reporting requirements seriously and we plan to address the requests in the Warning Letter expeditiously and holistically,” the statement read.