FDA Approves Mounjaro for Weight Loss Use, to Be Sold Under New Zepbound Name

Federal regulators have granted approval for a weight loss version of the Eli Lilly diabetes drug Mounjaro, which will be marketed under the brand name Zepbound, despite growing concerns over the adequacy of existing warnings about potential stomach paralysis side effects linked to Ozempic, Wegovy and other similar drugs.

Eli Lilly introduced Mounjaro (tirzepatide) last year, as part of a new generation of treatments for diabetes, which is a chronic and progressive condition that causes insulin resistance and insufficiency. It is part of the same class of new drugs as Ozempic (semaglutide), and both medications have been widely prescribed “off-label” for weight loss, given the positive effect they have helping to reduce hunger, decease food intake and promote feelings of fullness.

A separate version of Ozempic was previously approved by the FDA specifically for weight loss, which is marketed under the brand name Wegovy (semaglutide), and it has been widely anticipated for months that Eli Lilly would introduce a competing version of Mounjaro for weight loss.

This week, the U.S. Food and Drug Administration (FDA) issued a press release announcing the approval of Zepbound (tirzepatide) injections for chronic weight management among adults with obesity, indicating that clinical trial shave established that users experience a statistically significant reduction in body weight compared to those who received a placebo.

Concerns About Side Effects of Mounjaro, Ozempic and Wegovy

The FDA statement indicates that Zepbound side effects can include nausea, diarrhea, vomiting, constipation, abdominal pain and other symptoms. However, there have been a growing number of reports in recent months of some users experience severe and debilitating stomach paralysis from Ozempic, Wegovy and Mounjaro, sometimes resulting in intestinal obstructions, hospitalization and surgery.

As a result of the failure to disclose the potential long-term impacts of this condition, also known as gastroparesis, some former users are now pursuing Mounjaro lawsuits, Ozempic lawsuits and Wegovy lawsuits against the drug manufacturers, indicating that they could have avoided permanent injuries if the side effects had been properly disclosed.

The FDA indicates that clinical trials have shown that Zepbound injections, which is a larger dose than Mounjaro, though the drugs are basically identical, can lead to more than 20% average weight loss over 72 weeks. It is the strongest weight loss reduction signal seen with any FDA-approved drug to date.

“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in the press release. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

Zepbound Stomach Paralysis Risks

Some experts have raised concerns about the lack of specific warnings for users and the medical community about the increased risk of stomach paralysis from Zepbound, Mounjaro and Wegovy, which appear to be a direct side effect of the drugs’ primary mechanism of action, which delays gastric emptying. While this makes the user feel full longer and less hungry, the slow emptying can lead to stomach paralysis.

In July, the American Society of Anesthesiologists (ASA) issued a warning about using Ozempic and Wegovy before surgery, indicating that the lack of gastric emptying linked to the drugs could put patients at risk of vomiting and aspiration while under the effects of anesthesia. Similar side effects are linked to Mounjaro, which could also pose a problem during surgical anesthesia.

In 2017, researchers with the Mayo Clinic conducted a study involving a similar diabetes medication known as Victoza, which found that the drug caused significantly slower digestion in users, taking about 70 minutes for half the food they ate to leave their stomachs, compared to four minutes for people who did not take the drug. However, the study found that people’s bodies tended to adjust over time.

In September, the U.S. Food and Drug Administration (FDA) issued new label warnings for Ozempic, indicating that it can increase the risk of intestinal blockages. The warning links Ozempic to a condition known as ileus, which can cause abdominal cramps, bloating, nausea, vomiting, constipation, difficulty passing gas and difficulty eating.