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The maker of fat-loss drug Wegovy / Ozempic failed to report serious side effects including strokes, suicidal thoughts and deaths to the Food and Drug Administration (FDA).
The FDA issued a formal warning letter to Novo Nordisk this month for “serious violations” related to Wegovy / Ozempic and Saxenda, another weight-loss drug.
The letter followed FDA inspections conducted in January and February at Novo’s US base in Plainsboro, New Jersey.
Regulators concluded the company failed to comply with reporting requirements. Under federal law, pharma companies must report all serious reports of adverse effects to the FDA within 15 days of receiving them.
It was also found that the company failed to its own internal procedures, which included making follow-up enquiries to obtain safety information for serious cases involving reported deaths.
The company now says it is taking “corrective and preventative actions.”
The FDA’s letter details serious failings in the arguments used by Novo Nordisk to justify not investigating worrying reports of side effects.
Children’s Health Defense explains, “The letter detailed the case of a patient who experienced a disabling stroke after taking liraglutide (Saxenda). The company didn’t report it because it said the consumer didn’t think the stroke was related to the drug.
“In another case, a physician reported that a patient taking semaglutide committed suicide. Novo opted not to investigate the case.
“The company reported a different case of suicidal ideation to the FDA only after agency inspectors stumbled on the record when they were investigating the unreported stroke death…
“In another case, Novo said it didn’t investigate a patient death involving semaglutide (Ozempic, Wegovy) because the company hadn’t received consent from the person who reported the death. According to the FDA, consent isn’t required for PADE investigation.
“The FDA also found that even after the agency warned Novo that it was violating the law, its contractors continued to ‘inappropriately invalidate’ cases of serious adverse events. The company claimed the events were invalid because they lacked patient identifiers—protected information, such as name or social security number that links a person to their health record.”
The FDA claims the failure to report represent “systemic failures.”
“Based on the nature of the inspection’s findings and your written response and correspondence, we have serious concerns about the scope and impact of these violations on your entire product portfolio,” the FDA said.
Around 12%, or one in eight, US adults have now tried a weight-loss drug like Wegovy / Ozempic, Zepbound or Mounjaro, according to a poll, and about 6% are currently taking one. Over 40% of adults in the US are now obese.
The majority of those using the drugs (61%) are using them to treat a chronic condition like diabetes or heart disease. Just over 40% are diabetics.
In recent months, as publicity for and use of these new “miracle” drugs has grown tremendously, more attention has been drawn to their side effects. Psychiatric issues, hormonal problems including reduced testosterone and loss of libido, inhalation of the contents of the stomach, and even permanent lifelong diarrhea have been reported.
Tens of thousands of people are now suing the manufacturers of Wegovy / Ozempic and Mounjaro (Eli Lilly) for the physical damages they claim to have suffered.
