Lawsuits Over Ozempic Side Effects Are Brewing

A class action lawsuit alleges that manufacturers of Ozempic and similar drugs didn’t adequately warn the users about potential side effects. The lawsuit could be filed as soon as summer 2024, according to a law firm.

Ozempic and other novel type 2 diabetes drugs that belong to a class called GLP-1 agonists have been making the headlines for helping lose up to 20% of body weight. As many of these drugs are not approved by the U.S. Food and Drug Administration (FDA) for weight loss, some patients seeking to slim their waists use the medications off-label.

However, with the increasing use — 12% of American adults say they have ever taken a GLP-1 agonist — more and more users report experiencing severe side effects.

The King Law firm is currently investigating 117 lawsuits against Novo Nordisk, the manufacturer of Ozempic, and Eli Lilly, the maker of Mounjaro.

Plaintiffs say they weren’t warned of the consequences of using these medications, which include bowel injuries like gastroparesis (stomach paralysis), gastrointestinal obstruction, and ileus.

Gastroparesis is a condition where the stomach is unable to empty food normally and can cause heartburn, nausea, and vomiting. Gastrointestinal obstruction and ileus both involve the intestine being unable to push food and waste out of the body.

The defendants say that intestinal issues as side effects of these drugs were well known, including to doctors, who had an obligation to inform the patients.

In September 2023, the FDA added a new warning to the Ozempic label regarding the increased risk of ileus, calling it a serious but rare side effect.

Nausea, vomiting, diarrhea, abdominal pain, and constipation are the most common side effects of Ozempic, according to the drug label. It also warns that the drug delays gastric emptying and can increase the risk of pancreatitis and acute kidney injury, among other conditions.

However, there is currently a disagreement over what should be required to file a lawsuit: defendants seek plaintiffs to undergo a gastric emptying study, while the plaintiffs’ lawyers argue that a doctor’s diagnosis of these conditions should be sufficient, at least in the early stages of a lawsuit.

The lawsuit points to the lack of long-term data

Additionally, there are 87 personal injury lawsuits for gastroparesis, ileus and intestinal blockage or obstruction in multidistrict litigation before Judge Gene E.K. Pratter in the Eastern District of Pennsylvania, according to the Lawsuit Information Center.

The plaintiffs claim the drug labels do not adequately warn of potential severe injuries related to the drugs despite ongoing use and reported adverse effects.

Additionally, the complaint questions the safety of GLP-1 agonists due to the lack of long-term safety studies, as the longest study only extended to two years.

What is known about Ozempic side effects?

A 2022 systematic review associated the use of GLP-1 receptor agonists with an increased risk of gallbladder or biliary diseases, especially when taken at higher, for longer durations, and for the purpose of weight loss.

Research from 2023 associated the medications with an elevated risk of stomach paralysis, pancreatitis, and bowel obstruction in people without diabetes who use these drugs for weight loss.

However, type 2 diabetes patients using GLP-1 agonists are not at a higher risk of pancreatic cancer compared to those who use insulin only, according to a study published in JAMA Pharmacy and Clinical Pharmacology.

A 2024 study linked the use of GLP-1 agonists with rare but severe psychiatric events, such as depression, anxiety, and suicidal ideation. Another recent study found that people who use GLP-1 agonists are more likely to be dispensed with antidepressants. However, it does not prove that Ozempic raises depression risk.

After a thorough investigation, the European Medicines Agency concluded that the available evidence does not support a causal association between GLP-1 agonists and suicidal and self-injurious thoughts and actions. The conclusions echoed the findings of a similar preliminary review by the FDA.

People using GLP-1 agonists may be at an increased risk of thyroid cancer, as stated on the Ozempic label, although the evidence is inconclusive.

The class action lawsuits over Ozempic and other drugs' side effects may take several years to settle. Meanwhile, if you take GLP-1 agonists, discuss all new symptoms with your healthcare provider.