Labels on the diabetes drug Ozempic have been updated to acknowledge reports of a condition that interrupts the normal function of the intestines in some individuals who have used the medication.
The U.S. Food and Drug Administration (FDA) made the label update for the drug on Sept. 22.
It now clearly states that a gastrointestinal disorder known as ileus is among some of the adverse reactions that have been reported during post-approval use of semaglutide, which is the generic name for Ozempic.
The newly-updated label now reads: "Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure."
Ileus is a temporary lack of the normal muscle contractions of the intestines which can lead to food not being passed properly or waste not being moved through the body as it typically would, according to the Mayo Clinic.
Individuals may be more prone to ileus if they have undergone abdominal or pelvic surgery, contracted an infection, or if they have certain muscle and nerve disorders, such as Parkinson's disease, according to the Mayo Clinic.
Those who take certain medications that affect muscles and nerves, such as antidepressants and opioids, are also at increased risk of developing the digestive disorder.
Symptoms of ileus include abdominal cramps, loss of appetite, constipation, and vomiting along with an inability to pass bowel movements.
Ozempic Popularity SoarsThe updated label comes as Ozempic—which is manufactured by Danish pharmaceutical company Novo Nordisk and is used to control blood sugar in adults with type 2 diabetes—has soared in popularity as an off-label weight loss aid in recent months, leading to widespread shortages.
The medication works by stimulating insulin production and reducing glucose production in the liver, helping to lower blood sugar levels.
A similar diabetes drug, Mounjaro, which is made by Indiana-based American pharmaceutical firm Eli Lilly, works by targeting the body’s receptors for the hormone GIP (glucose-dependent insulinotropic polypeptide) and a natural gut hormone called GLP-1 (glucagon-like peptide-1), thus suppressing appetite and reducing food intake.
Both Ozempic and Mounjaro were recently named in a lawsuit filed by a Louisiana woman who accused the diabetes drug manufacturers of failing to adequately warn users that the medications can cause severe gastrointestinal problems including gastroparesis, which is effectively a paralysis of the stomach, similar to ileus.
In her 26-page lawsuit, 44-year-old Jaclyn Bjorklund claimed she suffered severe injuries as a result of using the two injectable prescription medications including severe vomiting, stomach pain, gastrointestinal burning, and a loss of teeth.
Semaglutide Adverse ReactionsThe lawsuit claimed that both Novo Nordisk and Eli Lilly "acknowledge that gastrointestinal events are well-known side effects of the GLP-1 class" but that they have "downplayed the severity of the gastrointestinal events caused by Ozempic and Mounjaro, never, for example, warning of the risk of gastroparesis ('paralyzed stomach') or gastroenteritis."
Gastroparesis, for which there is currently no cure, is also caused by diabetes itself.
Additionally, the woman's lawsuit states that neither manufacturer noted the risks of severe gastrointestinal events including gastroparesis and gastroenteritis when they announced they had received approval from the FDA.
The FDA has received 87 reports of adverse reactions after use of semaglutide medications, including those from Ozempic, this year alone and more than 400 since 2018, according to data published by the regulator through June 30.
Approximately 250 of the overall adverse reactions are owing to gastrointestinal disorders, among them ileus, the data show.
An FDA spokesperson told The Epoch Times in an emailed statement that the agency sees "intestinal obstruction as a potential signal of serious risk with glucagon-like peptide-1 receptors agonists (GLP1RAs) in the second quarter of 2022."
"After review of available data, the FDA determined that the term ileus, a decrease or interruption in the flow of intestinal contents without mechanical obstruction, better reflected the events described in the postmarketing cases and identified sufficient evidence to support a possible association between cases of ileus and the use of GLP1RAs," the spokesperson said. "As a result, the United States Prescribing Information for each GLP-1 RA was updated to include ileus in the Postmarketing Experience section."