GLP-1 manufacturers face dozens of lawsuits

GLP-1 drugs, which are used to treat diabetes and weight loss, have surged in popularity in recent years, with data showing that 40 times more GLP-1 prescriptions were written in 2023 compared to 2018. Two major manufacturers of the drugs are Novo Nordisk, which makes Ozempic, Wegovy, and Rybelsus, and Eli Lilly, which makes Trulicity, Mounjaro, and Zepbound.

"Everybody wants to be on these drugs," which are often viewed as "magic," said Clipper Young, a clinical pharmacist at Touro University California. According to KFF data, around 6% of the adult U.S. population, or over 15 million people, is currently taking GLP-1 drugs.

Although most patients taking GLP-1 drugs typically experience some gastrointestinal side effects, such as nausea, vomiting, or constipation, some patients have reported much more severe side effects. Some of these side effects include gastroparesis or stomach paralysis, intestinal blockage, inflammation of the pancreas, and gallbladder damage.  

"I couldn't keep anything down," said Monica Church, who was prescribed Ozempic by her doctor last October. "I couldn't eat anything. I couldn't drink anything. I had such burning in my stomach and in my chest that nothing helped." Church was later hospitalized for two weeks because of pain, vomiting, and gastroparesis.

As more reports of severe side effects emerge, dozens of lawsuits have been filed against Novo Nordisk and Eli Lilly by patients who claim that the companies did not adequately inform them about the potential risks of GLP-1 dugs.

So far, both companies have said the lawsuits are without merit and that they stand behind the safety and efficacy of their medications. The companies also noted their GLP-1 drugs have been assessed and approved by FDA and that the proven risks are included on product labels.

"Novo Nordisk stands behind the safety and efficacy of all of our GLP-1 medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional," said spokesperson Jamie Bennett.

"Patient safety is Lilly's top priority," said company spokesperson Jared Shapiro. "Our FDA-approved label clearly warns that Mounjaro may be associated with gastrointestinal adverse reactions, sometimes severe."

Is more research needed to understand the side effects of GLP-1 drugs?

Sandeep Palakodeti, a personalized healthcare entrepreneur, said the reports emerging about severe GLP-1 side effects are "definitely a signal that we need to investigate a little bit more."

According to Palakodeti, it's not unusual for new safety concerns to appear after a medication is already on the market. For example, research shows that post-approval safety issues emerged for a third of novel drugs approved between 2001 and 2010. Among these drugs, most were labeled with additional safety warnings, and a few were pulled from the market.

Currently, more research is needed on GLP-1 drugs to determine whether they are behind the severe side effects some patients have experienced, as well as their impact on long-term health. FDA has also requested more information about severe side effects being reported by patients and is "evaluating the need for regulatory action."

"We just don't have long-term data at this point," Young said.

Dana Filmore, who is considering potential litigation based on her health complications while on Ozempic, said all she wants is clarity about her experience with the drug. "Is this something I need to worry about for the rest of my life? Is it going to stop at some point? Is it going to get worse?" she said. "I would just like to know what I'm dealing with."

Advisory Board's weight-related resources

To help you address the growing use of weight management drugs, Advisory Board offers several resources:

This expert insight outlines the five biggest questions about weight management drugs and their answers. Similarly, this expert insight addresses what headlines get wrong about weight management drugs and what healthcare leaders should know instead.

Radio Advisory's Rachel Woods has also covered GLP-1 drugs on the podcast, discussing the potential future of these drugs and how they could help — or hurt — health systems' finances. Other useful resources include this expert insight on the five catalysts that will impact the future of obesity care and this research on four key elements of comprehensive obesity care.

Our weight management and obesity care resource library can also help leaders understand the current care landscape, manage innovations, and prepare for transformations in care. (Kim, Cincinnati Enquirer, 9/26; Ducharme, TIME, 11/4; Alltucker, USA Today, 3/22; Shultz, People, 9/5; Rutschman, U.S. News & World Report, 6/20)