FDA Approves Wegovy for Treatment of Obesity-Related Heart Problems, Despite Gastroparesis Risks

Novo Nordisk has convinced federal regulators to approve Wegovy, a weight-loss version of the diabetes drug Ozempic, for use as a preventative treatment against strokes, heart attacks and heart disease caused by obesity.

The U.S. Food and Drug Administration (FDA) issued a press release on March 8, announcing the approval of Wegovy for use against cardiovascular disease linked to being overweight. The agency indicated the drug should be used in addition to a reduced calorie diet and exercise.

Wegovy (semaglutide) is a higher-dose version of Ozempic, which is a blockbuster diabetes treatment that has been widely used “off-label” for weight loss. Although it contains the same active ingredient as Ozempic, Wegovy is specifically approved as a diet drug, and is now used by millions of Americans nationwide

Both Ozempic and Wegovy are part of a new class of medications known as glucagon-like peptide-1 receptor agonists (GLP-1 RA), which also includes Mounjaro and Zepbound, and are now viewed as breakthrough weight loss treatments that may provide a variety of other health benefits. However, concerns have emerged that certain users experience a painful and debilitating stomach paralysis, known as gastroparesis.

As a result of the drug makers failure fully disclose the gastroparesis risks on the warning label, a growing number of Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits are now being pursued, each raising nearly identical allegations that critical information was withheld from consumers and the medical community to increase profits.

The FDA indicates it granted approval for the new indications of Wegovy following a multi-national placebo-controlled double-blind clinical trial involving more than 17,600 participants, finding that the drug significantly reduced the risk of cardiovascular death, heart attacks and strokes.

“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” John Sharretts, director of the Division of Diabetes, Lipid Disorders and Obesity, which is part of the FDA’s Center for Drug Evaluation and Research,’ stated in the press release. “This patient population has a higher risk of cardiovascular death, heart attack and stroke.”

The FDA notes that obesity affects about 70% of American adults, and is a serious health issue. However, the approval comes amid growing concerns about the side effects of Wegovy and other GLP-1 drugs, and evidence that suggests the medications have been widely promoted for more and more uses without adequate warnings about serious stomach risks users may face.

Wegovy Gastroparesis Risks

Gastroparesis is a painful condition that impacts the stomach muscles and prevents proper stomach emptying. It is also sometimes referred to as stomach paralysis, gastric stasis or a gastric obstruction, and typically resulting in persistent nausea, vomiting and other complications, which often require repeated hospitalizations or medical visits.

A study published in October 2023 found that Ozempic triples the risk of the stomach paralysis among users when compared to users of non-injectable weight loss drugs. The research compared the gastrointestinal side effects of Ozempic and other injectable GLP-1 agonists like liraglutide (Victoza and Saxenda) against those experienced by users of Contrave (bupropion-naltrexone), an oral weight management medication.

The findings indicated that about 1% of Ozempic users developed stomach paralysis, compared to 0.7% of liraglutide users and around 0.3% of those on Contrave. The study highlighted that injectable semaglutide and liraglutide were significantly more likely to cause stomach paralysis and bowel obstruction than Contrave.

March 2024 Wegovy Stomach Paralysis Lawsuit Update

Given common questions of fact and law being presented in stomach paralysis lawsuits filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to centralize all GLP-1 lawsuits last month, transferring claims brought nationwide to U.S. District Judge Gene E.K. Pratter in the U.S. District Court for the Eastern District of Pennsylvania, for coordinated discovery and pretrial proceedings.

To establish the organizational structure for the growing litigation, Judge Pratter will hold an initial Wegovy lawsuit status conference on March 14, at which time the Court is expected to review the selection of a small group of plaintiffs’ lawyers who will serve in leadership roles throughout the litigation, taking certain actions that benefit individuals who experienced gastroparesis from Wegovy or other GLP-1 medications.

The parties will then move forward with additional discovery, to explore not only what the drug makers knew about the stomach paralysis risks, but also the marketing strategy that has pushed wider and wider use of the new medications, generating record profits, before the long-term side effects were well underestood.

As lawyers continue to review and file claims in the coming months, it is widely expected that thousands of claims will be transferred to the GLP-1 MDL, as nearly 2% of the U.S. population has been prescribed one of the GLP-1 medications, either for diabetes treatment or weight loss.

To help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation, Judge Pratter will likely establish a bellwether process to prepare a small group of gastroparesis lawsuits for early trial dates. However, if the parties are unable to negotiate Wegovy settlements or another resolution for the litigation after the bellwether trials, the Court may later remand each case back to the U.S. District Court where it was originally filed for trial.