The FDA has approved a new drug for weight management in patients with at least one weight-related health condition. According to the agency’s Nov. 8 announcement, the new drug, Zepbound, joins a controversial category of medications that face lawsuits such as Ozempic and Mounjaro.

Pharmaceutical company Eli Lilly is no stranger to hormone-mimicking weight loss drugs. The company already has another drug with the same active ingredient as Zepbound, tirzepatide. Zepbound mimics the naturally-produced hormone Glp-1, which helps regulate blood sugar by slowing the rate at which the stomach empties and suppressing appetite. Novo Nordisk also makes these types of drugs under the brand names Ozempic and Wegovy. 

The other drug that uses tirzepatide is the legally controversial Mounjaro. There have been lawsuits filed against Eli Lilly and Novo Nordisk over an array of injuries, including severe gastrointestinal complications after using Mounjaro and Ozempic. 

The influx of lawsuits and adverse events associated with Glp-1 mimicking drugs matches a rise in off-label uses. FDA-approved Glp-1 mimicking drugs like Zepbound are intended to help patients who struggle with being overweight or obese manage their hypertension, type 2 diabetes, or high cholesterol. However, because these drugs slow stomach emptying and suppress appetite, they have recently been used by non-obese people to lose weight. Because of the popularity of off-label use for Ozempic, shortages began to develop. 

This increased pattern of use sheds light on the many side effects that may come from using drugs like Ozempic, namely gastroparesis, a disorder in which food slows or stops moving from the stomach to the small intestine. Symptoms of gastroparesis include abdominal pain, nausea, and vomiting. The vomiting can be so intense that users can lose their teeth.

With the lawsuits against its other tirzepatide-based medication, it could be speculated that Eli Lilly is hoping to pivot away from Mounjaro by emphasizing the now-approved medication Zepbound. Zepbound is set to enter the market at a listed price of $1059.87 per month, according to Eli Lilly’s investor site.

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