Ozempic Lawsuits, Study Indicate Dangers; European Health Agencies Investigate
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Ozempic is a diabetes medication frequently prescribed off-label and deemed a “miracle weight loss” drug. The regulatory body for the UK has launched a probe into Ozempic regarding suicidal thoughts and self-harm. The Medicines and Healthcare Products Regulation Agency (MHRA) opened the investigation in July but has yet to present any findings. The European Medicine Agency (EMA) is reviewing 150 cases of self-injury and suicidal thoughts potentially caused by Ozempic. A new epidemiological study published in JAMA reveals concerns about pancreatitis and stomach paralysis.
Ozempic is a drug that contains semaglutide, which falls under the classification of Glucagone-Like Peptide-1 (GLC-1). The GLC-1 classification also includes liraglutide and dulaglutide. These drugs are used to treat diabetes and obesity, but Ozempic only has FDA and MHRA approval to treat diabetes. Semaglutide mimics a hormone that is naturally produced by the body. It slows down the passage of food in the stomach. This reduces a person’s appetite while making them feel fuller for a longer period of time.
The JAMA epidemiological study found semaglutide and liraglutide had over nine times higher risk of pancreatitis than another weight loss drug, bupropion-naltrexone. Semaglutide and liraglutide users also had a 4.2 times higher risk of bowel obstruction and a 3.6 times higher risk of gastroparesis, more commonly known as stomach paralysis.
Novo Nordisk is the pharmaceutical manufacturer of Ozempic, as well as GLC-1 products Wegovy and Victoza. While Ozempic is only FDA-approved to treat type 2 diabetes, the number of patients utilizing Ozempic for weight loss has more than doubled in most markets around the United States. This has caused a nationwide drug shortage, leading some pharmacies to compound versions that are not FDA-approved. Novo Nordisk recently filed a lawsuit alleging a Florida pharmacy was breaking the law by selling compounded versions of semaglutide, but the judge has dismissed the case.
It is illegal for pharmaceutical companies to market products for off-label uses, which was the basis for a false claim lawsuit settlement against Novo Nordisk in 2017 and their liraglutide product, Victoza. Elizabeth Kennedy, a former sales team employee for Novo Nordisk, filed suit and claimed that the pharmaceutical company told the sales team to refrain from discussing the thyroid cancer black box warning while encouraging off-label use of the drug for weight loss. Victoza settled to pay 46.5 million and was immediately sued by the federal government for another 12.1 million. In the case with the government, Novo Nordisk was required to admit that they trained their employees to undermine the Risk Evaluation and Mitigation Strategy. The company was earning over 2.5 billion per year from sales of this product at the time.
Novo Nordisk responded to a request for comment and provided corporate statements. “Although Wegovy® and Ozempic® contain semaglutide, they are different products with different indications, dosages, prescribing information, titration schedules, and delivery forms. The products are not interchangeable and should not be used outside of their approved indications.”
Despite that warning, there are Facebook advertisements from Dr. Goglia, known as the nutritionist for the stars. The advertisements look to cash in on rubber stamp approvals of Ozempic and other diabetes/weight loss drugs, some of which are being promoted for off-label use. On Ozempic’s website, they have a page that promotes the higher weight loss that Ozempic provides over similar GLP-1 type 2 diabetes medications. While not overtly marketing the drug as a weight loss drug, Ozempic literature is clear about the benefits for weight loss while stating in smaller font that the drug is not FDA-approved for weight loss.
Elon Musk recently made a statement on X regarding Ozempic reducing food sales at Walmart. His post is in response to Walmart CEO John Furner speaking to Bloomberg News about tracking users of the drug and their overall sales in the department store. “We definitely do see a slight change compared to the total population,” Furner said. “We do see a slight pullback in the overall basket.” Even despite fewer sales in the food department, Walmart is still seeing an increase in overall sales from those using Ozempic and Wegovy.
In the clinical trials, Ozempic reports that 34 percent of (2 mg dose) study participants had adverse gastrointestinal reactions, and 30 percent had a 1 mg dose. A black box warning also says, “In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures.” The warning also states that it is unknown if semaglutide would cause thyroid C-cell tumors in humans. The European Medicines Agency (EMA) is also investigating the drug for potential links to thyroid cancer. A study published in February 2023 indicates an increased risk of thyroid cancer and medullary thyroid cancer after 1-3 years of treatment.
The first lawsuit alleging Ozempic causes gastroparesis or stomach paralysis has been filed in the U.S. District Court in Louisiana. The attorneys from the firm Morgan and Morgan are alleging Novo Nordisk failed to warn of these dangers and believes that semaglutide drugs, including Ozempic and Mounjaro, are causing gastroparesis. They intend to file many more lawsuits, and attorneys nationwide are looking for injured clients for more potential litigation against the pharmaceutical manufacturer.
In Novo Nordisk’s response to the risk of gastroparesis, they indicate that diabetes is a well-known risk factor for gastroparesis, alongside being female or obese, among other conditions. They further state, “GLP-1’s are known to cause a delay in gastric emptying, as noted in the label of each of our GLP-1 RA medications. Symptoms of delayed gastric emptying, nausea, and vomiting are listed as side effects.”
Watch Jefferey Jaxen’s report on Ozempic from Episode 330 of The HighWire here.
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