FDA Updates Ozempic Safety Label to Account for Severe Intestinal Obstruction

In late September, the Food and Drug Administration issued a revision of the Ozempic warning label to address the antidiabetic-turned-weight loss medication’s potential to cause life-threatening bowel blockage (ileus). Ozempic manufacturer, Novo Nordisk, told prominent news outlets that it intends to work in close conjunction with the FDA to ensure the safety and efficacy of its GLP-1 medications that are the subject of many Ozempic lawsuits. 

Nevertheless, the move comes at a time when the once unrivaled pharmaceutical company has become beleaguered with Ozempic lawsuits, transatlantic investigations, and heightened scrutiny from the press, public, and physicians. Although the move reaffirms the FDA’s commitment to post-marketing oversight, it also reveals the formerly undisclosed potential for approved medications to threaten user safety. 

Reports of Gastrointestinal Distress Linked to Ozempic Flood FDA Submission Portal

The U.S. Food and Drug Administration (FDA) has, in recent days, unveiled a revision to the warning label of the popular antidiabetic medication, Ozempic. The consequential decision comes as a response to mounting reports on the agency’s public-facing submission portal which allege severe intestinal blockages connected to semaglutide use. 

For post-marketing oversight, the FDA operates a database for the fielding of user, physician, and manufacturer reports about the defective design of or complications associated with FDA-approved products. The FDA Adverse Event Report System (FAERS) serves a critical role in ensuring that users and prescribers are fully informed of the potential risks they incur when receiving treatment. 

According to CBS News, as of June 2023, the FDA had published over 8,500 semaglutide adverse event reports (AERs), 33 of which involved incidents of ileus. Two of the reports, allegedly, proved lethal. 

Novo Nordisk Assures Users of Protocol Compliance and FDA Cooperation

The FDA’s Drug Safety-related Labeling Change (SrLC) prompted a flurry of reporting from major American media, which contacted both the agency and Novo Nordisk, the manufacturer of Ozempic. In response to inquiries, the company, now the most valuable in Europe, said that it works “to continuously monitor the safety profile of our medications”. 

Nevertheless, acutely aware of the specter of liability and litigation, Novo Nordisk told The Hill that it “stands behind the safety and efficacy of Ozempic” in spite of the safety label update. Emphasizing the importance of appropriate drug prescription and administration, it went on to tell CBS News that its medications are effective, provided they are “used consistent with the product labeling and the approved indications”.  

How Does Ozempic Cause Ileus?

In May 2023, Acta Pharmaceutica Sinica B published a revelatory clinical study that analyzed the relationship between glucagon-like peptide 1 (GLP-1) receptor agonist medications and a heightened risk of developing bowel obstructions. They found that GLP-1 RAs, although designed as analogs to the naturally occurring GLP-1, also trigger the small intestine to release GLP-2

GLP-2 is another hormone that, amongst other things, has a direct impact on the growth of the small intestine. Over extended periods, medications like Ozempic have the potential to cause the secretion of so much GLP-2 that the hormonal surplus can elongate the intestine and increase its height. 

These physiological changes may compound the already heightened risk of constipation associated with GLP-1 RA medications, which, in effect, increases the likelihood of a long-term user developing ileus. However, the short-term duration of most clinical trials complicates medical research, because the rate of developing bowel obstructions in GLP-1 RA users often occurs after a year and a half of sustained use. 

Concluding that the new swath of antidiabetics and their weight management spinoffs have the potential to result in lethal complications, the study argues that clinicians ought to be informed of the “emergence of chronic adverse events of GLP-1 RAs” to avoid “erroneous inferences”. 

GLP-1 RA Drugs Linked to Severe Gastrointestinal Complications

Although more conservative in addressing the media, Chanapa Tantibanchachai of the FDA sought to allay fears and avoid confusion by informing the public that ileus is, ultimately, not directly connected to another health complication associated with Ozempic which is gastroparesis. The comment reflected a recent effusion of concern amongst physicians and users about the potential the popular antidiabetics have to result in stomach paralysis and an assortment of equally unpleasant and undisclosed side effects. 

Can Ozempic Cause Gastroparesis?

One of the most serious medical complications connected to Ozempic use is gastroparesis, colloquially known as stomach paralysis. GLP-1 RA medications mimic the naturally occurring GLP-1 produced in the lower intestine, which, in Type II diabetics, triggers the release of insulin in the pancreas for the regulation of blood sugar levels. 

However, it can also decrease the rate at which the stomach empties. In more extreme instances, the muscles that facilitate gastrointestinal motility can slow to a dangerous pace, resulting in stomach paralysis, whose symptoms include: 

Ozempic Connected to Cyclic Vomiting Syndrome (CVS)

Summer reporting from CNN revealed the potential Novo Nordisk’s Wegovy and Ozempic have to cause cyclic vomiting syndrome (CVS), a severe condition characterized by periods of intense nausea followed by profuse vomiting. In an interview with the outlet, Ozempic user Emily Wright disclosed the nature of her CVS diagnosis, stating that it required her to take a leave of absence from her job as a schoolteacher in Toronto. 

Despite ceasing the use of Ozempic, Wright still struggles with the condition, which may result in:

  • Recurrent vomiting episodes
  • Crippling abdominal pain
  • Headaches
  • Fatigue

Ozempic Manufacturers Held Accountable in Court of Law 

Although Novo Nordisk now enjoys unparalleled supremacy in the GLP-1 RA pharmaceuticals industry, it is not immune to litigation for potentially irresponsible business practices. The Ozempic and Wegovy manufacturer refers to gastrointestinal complications on the warning labels of its various drugs, but does not explicitly address and fails to recognize their potential to cause gastroparesis or cyclic vomiting syndrome. 

Consequently, in August 2023, both Novo Nordisk and Eli Lilly and Company, the manufacturer of Mounjaro, were faced with an alarming GLP-1 product liability lawsuit from Louisiana. The official complaint in the Mounjaro lawsuit outlines in excruciating detail the severity of the gastroparesis and undiagnosed recurrent vomiting the plaintiff suffered after taking Ozempic and, subsequently, Mounjaro.

The Ozempic lawsuit may also be the first of many to come despite being the first of its kind. Ozempic is also not alone in this litigation since many are also filing Mounjaro stomach paralysis lawsuits as well. Alleging that the major producers of GLP-1 RA medications failed to warn users of the risks associated with the use of their drugs, the litigation will likely serve as a template for future cases. 

Common Damages in Ozempic Lawsuits

The medical complications linked to Ozempic use can have life-altering consequences. Depending on the circumstances, some such injuries may be compensable. For example, the costs associated with the long-term use of GLP-1 RAs pale in comparison to the medical expenses an individual may incur from treatment to address their severe side effects.

If you took Ozempic and subsequently developed any of the symptoms of gastroparesis, cyclic vomiting syndrome, and other related complications, you may be entitled to compensation for: 

  • Lost income and wages
  • Medical expenses – past, present, and future
  • Decreased quality of life
  • Emotional distress

Ultimately, each case is unique, which means that the best way to determine the compensation to which you may be entitled is to consult with an experienced Ozempic attorney for more details. 

Read more about the Ozempic Gallstone Lawsuit or Speak to an Ozempic Gallstone Lawyer

Qualified Ozempic Lawyers Can Help

At LLN, we believe that Novo Nordisk cut corners to make a profit and, in the process, critically endangered the public. When massive pharmaceutical companies downplay the health risks associated with their drugs, they deserve to be held accountable for the lives and livelihoods they upend. 

That is why our experienced team of Ozempic lawyers is on standby to offer you the assistance and guidance you need. In a free consultation, you can learn more about the eligibility of your claims and receive necessary advice about how best to proceed. 

Deciding to undertake a high-profile Ozempic product liability lawsuit may seem daunting, but a refusal to take action may further jeopardize your future by depriving you of the chance to get the compensation you deserve. With round-the-clock service and a proven track record of client success, our legal team will work tirelessly to protect your rights as you safeguard your health.

Latest News