The FDA issued a safety-related drug labeling change on Ozempic, listing ileus as a possible adverse reaction to the weight loss drug.
On September 22, the FDA revised Ozempic's product label, adding a gastrointestinal condition that can result in blocked intestines as a possible adverse effect from using the medication.
In light of post marketing adverse reaction reports, the label now says that Ozempic (semaglutide), manufactured by Novo Nordisk, may cause an adverse effect called ileus — a condition in which muscle contractions in the intestines slow or stop. This halt in contractions can cause blockages in the digestive tract.
According to the FDA, the agency has received reports of individuals experiencing ileus while using Ozempic. However, the FDA notes that "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."
Wegovy and Mounjaro — other semaglutide weight loss/diabetes medications — already list ileus as a possible side effect on their labels.
In addition to label changes regarding the potential for Ozempic to cause blocked intestines, the FDA also added a warning for people taking insulin or an insulin secretagogue while on the medication.
The agency notes, "Patients receiving Ozempic in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia."
Other adverse side effects of Ozempic spark concern
Because of the popularity of medications like Ozempic, health experts are becoming more concerned about semaglutide’s potentially harmful side effects.
For example, reports suggest that semaglutide could cause malnutrition and may lead to stomach paralysis. In addition, the European Union is investigating reports of suicidal thoughts among people using the weight loss drug.
Moreover, in the United States, Reuters reports that since 2010, the FDA has received 265 reports of suicidal thoughts or behavior in people taking Ozempic, Wegovy, and similar drugs, including 36 deaths by suicide or suspected suicide.
Still, semaglutide has helped many people lose weight and may improve insulin dependency in people with diabetes. Research also suggests the medications may help reduce the risk of heart attack or stroke in specific populations.