In the past few years, Ozempic, a prescription drug for the treatment of Type-2 diabetes, has become a household name. As weight loss became a widely known side effect of the drug, Ozempic and other similar medications began to skyrocket in popularity due to its off-label use. Just this year, Ozempic experienced a 111% increase in prescriptions from 2022. Its increase in popularity, however, has not been without scrutiny. There have been reports of adverse gastrointestinal effects from the medication, and recently, a lawsuit was filed against the manufacturers of Ozempic and Mounjaro, another similar drug. With the recent lawsuit looming, and as more reports continue to unfold, it is likely that Ozempic may find itself in defending against mass tort claims.
What is Ozempic?
Ozempic, which is manufactured by Novo Nordisk and known by its generic name, semaglutide, is a weekly injectable drug used to manage blood sugar levels in adults with type-2 diabetes as well as lower risks of heart attack and stroke for diabetics. Ozempic belongs to a class of drugs called glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and lowers blood sugar by helping the pancreas produce more insulin. Ozempic was approved by the U.S. Food and Drug Administration in 2017 for its use in adults with type-2 diabetes. Ozempic is not approved by the FDA for weight loss, although weight loss is a common side effect, as the drug slows digestion and mimics a naturally occurring hormone that tells your brain it is full. As a result, Ozempic surged in popularity as an off-label weight loss drug, with data indicating an increase in users that were not diagnosed with diabetes. Celebrity use and promotion of the drug also catapulted Ozempic into widespread notoriety, which caused a drug shortage for patients who actually rely on it for diabetes.
Another drug, Wegovy, with the same active ingredient as Ozempic, was introduced in 2021 but unlike its predecessor, was specifically approved for weight loss management. Similar to Ozempic, Wegovy’s demand also skyrocketed, resulting in drug shortages. Mounjaro, a drug manufactured by Eli Lilly and Co. and known by the name tirzepatide, is another GLP-1 drug in the same class as Ozempic, but also utilizes another hormone, glucose-dependent insulinotropic polypeptide (GIP), which increases its efficacy. Although Mounjaro can cause significant weight loss, it is not currently approved for that purpose. In part due to the rapidly increasing popularity of these drugs, the prescription weight loss drug market surpassed its 72% forecasted growth in 2022, and is expected to reach an estimated $1.9 billion this year. Currently, Ozempic comprises more than 40% of the United States market share of GLP-1 agonists and holds the largest share of the markets for this drug class.
In 2021, the FDA received more than 100,000 adverse events from users of semaglutide-related drugs, complaining of gastroparesis and stomach paralysis, a disorder also referred to as gastric emptying, which slows or stops the movement of food from the stomach to the intestines. Recent studies have also indicated that the drug may increase the risk of gallbladder and biliary diseases.
The Lawsuit’s Allegations
In a lawsuit filed in federal court this month against the manufacturers of Ozempic and Mounjaro, a Louisiana woman, Jaclyn Bjorklund (age 44), claims that the companies failed to sufficiently warn her about the risk of severe gastrointestinal events. The plaintiff was using Ozempic for over a year when she recently began using Mounjaro in July 2023. According to the complaint, she suffered from severe gastrointestinal events such as severe vomiting which caused the loss of teeth, stomach pain, and gastrointestinal burning, requiring several hospitalizations and emergency room visits.
The plaintiff concedes that the companies acknowledged that gastrointestinal events are well-known side effects of these drugs, but asserts that the severity of the effects was downplayed, and that both companies failed to warn about the risk of gastroparesis or gastroenteritis. The complaint cites Ozempic’s marketing strategies for off-label weight loss use, which included advertisements of adults losing “on average up to 12 pounds” and notes that Novo Nordisk spent approximately $11,000,000 to promote the medication to physicians. According to the complaint, Ozempic prescriptions reached an all-time high in February 2023, with one weeks’ worth totaling 373,000. Likewise, Eli Lilly engaged in similar marketing campaigns for Mounjaro, with news articles touting it as potentially “even more powerful” than Ozempic even though it had not be designated by the FDA for weight loss.
How Can the Experts Weigh in?
Ozempic has already been on the radar of a number of medical experts and regulatory authorities. The FDA has received adverse event reports from users of these drugs, although an FDA spokesperson said it was unclear whether GLP-1 medications contribute to gastroparesis. As further stated, "if newly identified safety signals are identified, the FDA will determine what actions are appropriate after a thorough review of the body of evidence."
The complaint cites August 2020 medical literature that found GLP-1 drugs “can exacerbate the symptoms of diabetic gastroparesis” and would not be recommended for patients with these symptoms. In addition, the American Society of Anesthesiologists issued a warning on June 29, 2023 that patients should cease this medication at least a week prior to surgery due to the delay of gastric emptying and its increased risk of regurgitation and aspiration of food into the airways and lungs during anesthesia and deep sedation.
Gastroenterologists will likely be needed to opine as to the exact risks associated with the drug and how it affects the gastrointestinal system. Experts in the fields of weight management may also offer opinions as to the safety of these drugs for the purposes of weight loss, in light of the significant obesity epidemic in the country. "If everybody who had obesity in this country lost 20% of their body weight, we would be taking patients off all of these medications for reflux, for diabetes, for hypertension," Dr. Caroline Apovian, a director of the Center for Weight Management and Wellness at Brigham and Women's Hospital explained. "We would not be sending patients for stent replacement."
In the meantime, it is likely that litigation will not slow down, as attorneys field thousands of inquiries from the high number of recent Ozempic patients.