FDA updates Ozempic label to include warning for intestinal blockage, hypoglycemia risk
Click Here to Manage Email Alerts
The FDA has updated the label for Ozempic to include the potential risk for ileus, or an intestinal blockage, as well as increased risk for hypoglycemia if used in combination with insulin or insulin secretagogue.
The use of glucagon-like peptide-1 (GLP-1) receptor agonists for diabetes and weight loss management – including semaglutide (Ozempic/Rybelsus/Wegovy, Novo Nordisk) – have previously been linked to adverse GI events such as abdominal pain, constipation, diarrhea, nausea and vomiting. Following post-marketing adverse reaction reports of patients who developed ileus while prescribed Ozempic, the FDA has opted to revise the drug label to alert prescribers of this potential risk.
However, the agency noted 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.”
In addition to the risk for ileus, the FDA also warned against concomitant use of Ozempic with insulin secretagogue or insulin due to the risk for hypoglycemia.
“Ozempic stimulates insulin release in the presence of elevated blood glucose concentrations,” the agency noted. “Patients receiving Ozempic in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia.”
These drug label changes come shortly after a personal injury lawsuit alleged that the manufacturers for Ozempic and Mounjaro (tirzepatide, Eli Lilly) had “downplayed the severity” of the gastrointestinal events in the prescribing information, and had omitted risks of gastroparesis or gastroenteritis.
References:
- Drug Safety-related Labeling Changes (SrLC). https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2183. Accessed Sept. 29, 2023.
- Highlights of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf. Accessed Sept. 29, 2023.