The FDA Adds Intestinal Blockage Warnings to Ozempic Drug Label

The U.S. Food and Drug Administration (FDA) recently updated the label for Ozempic, a popular medication used in the treatment of type 2 diabetes, to include a potential risk of intestinal blockage, also known as ileus. This update comes in response to postmarketing reports of patients developing blocked intestines after taking Ozempic. While the FDA acknowledges these reports, they emphasize that the exact frequency and causal relationship to the drug are still uncertain.

What is Ozempic?

Ozempic (semaglutide) belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. These medications work by mimicking a hormone called GLP-1, which helps regulate blood sugar levels and control appetite. Originally intended to treat patients with type 2 diabetes, Ozempic has gained popularity as an off-label treatment for weight loss. The FDA approved Ozempic in 2017 for type 2 diabetes and then approved Wegovy (the same drug in a higher dose) in 2021 for weight loss in adults with obesity or those who are overweight and have at least one weight-related health condition. 

Potential Risks of Intestinal Blockage

The new warning added to the Ozempic label highlights the potential risk of ileus, a condition in which the intestines temporarily lose their ability to contract, leading to a blockage. Common symptoms of ileus include cramping, pain, the inability to have a bowel movement, swelling, vomiting, and a lack of appetite. Ileus can be a serious condition that often requires medical intervention, including hospitalization and, in severe cases, surgery.

Ozempic Injury Reports and Lawsuits

Since 2018, there have been over 14,000 reported adverse effects associated with Ozempic, with nearly 9,000 of them related to various gastrointestinal issues. These reports, including instances of ileus, prompted the FDA to update the drug’s label. Additionally, the manufacturers of Ozempic and similar GLP-1 agonist medications may face injury lawsuits filed by patients who claim to have suffered severe gastrointestinal issues while taking the drugs. 

A lawsuit filed in August 2023 in the U.S. District Court for the Western District of Louisiana was the first to allege that Ozempic and another diabetes drug called Mounjaro can cause gastrointestinal injuries in users. The plaintiff, Jaclyn Bjorklund, of Louisiana, states in her claim that the drug makers failed to disclose serious health problems allegedly caused by their medications, including stomach paralysis, also known as gastroparesis.

Ozempic Treatment May Still Offer Benefits

While the label update serves as an important warning of the potential side effects of Ozempic, the possible benefits of the drug should not be disregarded. Ozempic and its sister drug, Wegovy, have soared in popularity over the last year, and some patients say the benefits they got from the medications outweighed the side effects. However, it is imperative that Ozempic users are aware of the potential risks associated with the drugs and discuss them with their healthcare providers, especially when prescribed Ozempic off-label for weight loss. 

Other Medications and Similar Risks

It’s important to note that Ozempic is not the only medication in its class to carry warnings of gastrointestinal issues. Wegovy, the higher-dose formulation of semaglutide also manufactured by Novo Nordisk, and Mounjaro, a diabetes medication produced by Eli Lilly, have similar warnings regarding intestinal blockage. In fact, the labeling for Wegovy already includes ileus as a potential adverse reaction.

The FDA’s Role and Future Research

The Ozempic label update reflects the FDA’s commitment to monitoring and addressing potential risks associated with the diabetes medication. The agency notes in the adverse reactions section of the revised drug label that the reports of adverse effects are voluntary and come from a population of uncertain size, making it difficult to establish a definitive causal relationship. Ongoing research and monitoring will continue to shed light on the risks and benefits of medications like Ozempic.

All Medications Carry Potential Risks

The FDA’s recent update to the Ozempic label serves as a reminder that all medications carry potential risks. Patients prescribed Ozempic should be aware of the possibility of intestinal blockage and other gastrointestinal disorders and should consult with their healthcare providers about any concerns. While the risks exist, it’s important to remember that many individuals have benefited from Ozempic’s intended use in managing type 2 diabetes. As with any medication, open communication with healthcare professionals is key to ensuring the best possible outcomes for patients.