Semaglutide, the active ingredient found in the widely used anti-diabetes and anti-obesity drugs Ozempic and Wegovy, respectively, are linked to an increased risk of thyroid cancer in patients who take the drugs in accordance with a doctor's prescription.
Known as glucagon-like peptide-1 (GLP-1) receptor agonists, the drugs in question are manufactured by Novo Nordisk, AstraZeneca, Eli Lilly and Sanofi Winthrop, all of which must submit supplementary information about them to the EMA by July 26, 2023.
While a safety signal does not necessarily imply a direct causal relationship between a drug and the reported adverse event, the EMA uses it to help better determine whether or not a causal link exists by examining whatever the drug manufacturers send its way as part of the supplementary information requirement.
"Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic," said Lars Otto Andersen-Lange, the media relations director at Novo Nordisk, in a statement.
Andersen-Lange added that all associated Novo Nordisk products, including semaglutide, have been on the market for more than a decade, and that the safety data gathered from post-marketing surveillance of the drugs has not shown any "conclusive" evidence tying them to thyroid cancer.
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Big Pharma criticizes researchers for exposing thyroid cancer risk of anti-diabetes, anti-obesity drugs – says their study contains "important limitations"
As usual, Novo Nordisk and the other drug companies responsible for producing the offending drugs continue to deny that their products are in any way unsafe. In fact, they even went so far as to take aim at the new study exposing the link, claiming it contains "important limitations."
Some of the "important limitations" highlighted by Andersen-Lange includes the absence of validated case identification, inadequate differentiation of recurrent events, potential misclassification of events, and unconfirmed drug exposure, to quote one media source.
The study in question was pioneered by French researchers who looked at data from the French national health care insurance system database. From this, they noticed an increased risk of thyroid cancer among individuals who take the drugs in question, particularly between one and three years of being on them.
Diabetes Care reportedly published two commentaries on the study, one of which suggests that "detection bias" could be making it seem like the drugs cause thyroid cancer when they really do not. The other suggests the study might be invalid because it did not account for obesity as a confounding factor in thyroid cancer.
Interestingly, Novo Nordisk's prescribing information for Ozempic and Wegovy contains a warning about the risk of developing thyroid C-cell tumors. The manufacturer also notes in the prescribing literature that semaglutide is linked to "dose-dependent and treatment-duration-dependent thyroid C-cell tumors" in rodents, but that human cancers remain "undetected."
Those with a family history of thyroid cancer are warned against taking Wegovy by the FDA, which seems to be in acknowledgement that something is very wrong with these drugs in terms of their cancer risk.
It turns out that a big factor in Novo Nordisk's success as a drug company is due to semaglutide. The company is now the second most valuable company in Europe, trailing only behind the French luxury goods group LVMH.
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