FDA Approves New GLP-1 RA Weight Loss Drug 

FDA Approves New GLP-1 RA Weight Loss Drug 

Eli Lilly and Company made considerable inroads in the antidiabetic medication market with its blockbuster tirzepatide drug, Mounjaro. On account of its potent “dual agonist” formula and pronounced weight loss potential, physicians and users alike hailed the drug as the “new Ozempic”. 

In an effort to capitalize on growing demand and Wegovy shortages, Eli Lilly and Co. sought to fast-track the review process for its latest GLP-1 RA, Zepbound. In development since 2017, the medication received FDA approval on November 8, 2023, for chronic weight management. 

Although the decision elicited a wave of enthusiasm from prospective users and physicians, skepticism and scrutiny about the safety of long-term GLP-1 RA use continues to grow. In the aftermath of the first Ozempic and Mounjaro stomach paralysis lawsuit in August 2023 and a slew of clinical research and exposés, the recent development raises concerns about the rate at which potentially harmful weight loss drugs have taken the country by storm. 

Zepbound Eli Lilly and Company’s Latest Tirzepatide Medication 

The FDA approved Zepbound for chronic weight management. Eli Lilly and Company’s first tirzepatide medication, Mounjaro, was approved in 2022 for the treatment of Type II diabetes. 

Although Eli Lilly has been developing Zepbound since 2017, the company’s effort to acquire a weight management designation parallels Novo Nordisk’s move to repurpose Ozempic’s semaglutide formula for Wegovy. 

Who Should Take Zepbound? 

Zepbound is designed for those who suffer from obesity or are overweight with at least one weight-related condition, which could include: 

  • Type II diabetes
  • High cholesterol 
  • High blood pressure

When paired with reduced caloric intake and increased exercise, the FDA discovered that the new tirzepatide drug could result in considerable weight loss when taken in high dosages and over the long term. 

Side Effects of Zepbound 

In contrast to other GLP-1 RAs, Zepbound is a “dual agonist” that mimics two critical hormones produced in the lower intestine. Consequently, it has a pronounced impact on the functioning of the gastrointestinal system and may result in the same side effects as other beleaguered medications in the drug class. 

In clinical trials, the FDA observed that Zepbound has the potential to cause a variety of disruptive and painful side effects, including: 

  • Nausea 
  • Vomiting
  • Diarrhea
  • Abdominal pain

The introduction of Zepbound has already raised concerns over medicinally-induced gastroparesis, which clinical research has connected to GLP-1 RA use. The FDA did not test Zepbound on those who have a history of gastrointestinal diseases or conditions and advises such individuals to avoid the medication. 

Eli Lilly and Co. Seeks Streamlined Approval Amidst Mounjaro Lawsuit

In 1992, Congress ratified the Prescription Drug User Fee Act (PDUFA) which contains provisions for streamlined approval procedures for medications that improve upon or supplement the treatment, prevention, or diagnosis of a “serious condition”. 

Relying upon the act’s regulatory framework, Eli Lilly and Co. submitted an application to the FDA for a Priority Review, citing the growing obesity epidemic in the United States and the enhanced weight loss potential of the drug. In addition, the FDA accepted the company’s request for a Fast Track review, which is designed to expedite the approval procedures for medications that satisfy an “unmet medical need”. 

What Are GLP-1 RAs?

Zepbound is a unique member of a growing class of medications known as glucagon-like peptide 1 receptor agonists (GLP-1 RAs), which includes:

  • Saxenda (liraglutide) 
  • Trulicity (dulaglutide) 
  • Ozempic (semaglutide) 
  • Rybelsus (semaglutide) 
  • Wegovy (semaglutide) 

The drugs mimic the naturally occurring GLP-1 hormone, which stimulates the pancreas to release insulin and increases a person’s sense of fullness at mealtime. However, GLP-1 RAs also have the potential to slow the rate at which the stomach empties. 

By contrast, tirzepatide is a “dual agonist”, which mimics both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Consequently, it has a heightened impact on the gastric system and, Eli Lilly argues, far greater weight loss potential. 

Semaglutide and Tirzepatide Linked to Severe Gastrointestinal Complications

Although the excitement over potentially revolutionary weight loss drugs is understandable, there are considerable risks that prominent GLP-1 RA manufacturers failed to disclose to the public. For example, a growing number of Ozempic and Wegovy users have reported developing serious medical complications, including: 

One of the major recent studies investigating the link between medicinally-induced conditions and GLP-1 RAs came from the Journal of the American Medical Association (JAMA) in October 2023. The researchers discovered that the risk of developing medicinally-induced gastroparesis from GLP-1 RAs was high even in those who were not predisposed to the condition. 

Mounjaro and Ozempic Product Liability Lawsuit Filed in Louisiana 

Eli Lilly and Co. was listed as a co-defendant, alongside Novo Nordisk, in a first-of-its-kind Ozempic stomach paralysis lawsuit in Louisiana in August 2023. The development piqued public and clinical suspicions about the forthrightness of both pharmaceutical companies’ side effects disclosures. 

The plaintiff, then 44-year-old Jaclyn Bjorklund, alleges that she took Ozempic for around a year before subsequently developing unpleasant gastrointestinal side effects. Upon the advice of her doctor, she abandoned Ozempic in July 2023 and began to take Mounjaro instead, which only exacerbated her medical conditions. 

Shortly after taking Mounjaro, Bjorklund developed intense gastric distress and was afflicted by gastrointestinal burning, abdominal pain, and prolonged periods of vomiting, which resulted in the loss of teeth. On at least one occasion, Bjorklund was hospitalized and had to take trips to the emergency room. 

Bjorklund’s Mounjaro and Ozempic product liability lawsuit alleges that Novo Nordisk and Eli Lilly and Company “failed to warn” users about both the severity and the duration of their GLP-1 RA and GIP medications’ side effects. The official complaint goes so far as to assert that the pharmaceutical companies “downplayed” the risks of their medications, in spite of highly alarming evidence from clinical trials. 

Common Damages in Ozempic and Mounjaro Lawsuits

In defective drug lawsuits, injuries can vary from temporary disruptions to life-altering consequences. As Bjorklund’s Ozempic and Mounjaro lawsuit displays, GLP-1 RA and double agonist medications can result in long-term changes in one’s daily life and cause emotional and mental distress. 

Fortunately, these damages may be compensable. If you took Ozempic or Mounjaro and developed the symptoms of gastroparesis, gastroenteritis, or cyclic vomiting syndrome, you may be eligible to hold Novo Nordisk and Eli Lilly and Co. to account for their failure to warn you of the side effects of their medications. 

Common damages in ongoing Ozempic lawsuits include: 

  • Medical expenses 
  • Loss of income 
  • Pain and suffering
  • Mental anguish
  • Decreased quality of life

Contact an Experienced Product Liability Lawyer for Your Ozempic Lawsuit

If you or a loved one have used Ozempic or Mounjaro and subsequently developed severe medical complications, we want to help. With over 120 combined years of personal injury law experience and the track record to prove it, our talented legal team of Ozempic product liability lawyers have the skills and experience to determine if Novo Nordisk is liable for your injuries and can determine the compensation to which you may be entitled. 

In a free consultation, we can assess the eligibility of your claim and assist you in making the critical decision on whether or how to file an Ozempic lawsuit. For more information, consider contacting us today. 


Matthew Dolman

Personal Injury Lawyer

This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.

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