Is Lixisenatide safe?
Trial and label safety data
Nausea, vomiting, and diarrhea were the most common side effects in the trials. They were the main reason for stopping. In ELIXA, rates of serious side effects did not differ from placebo. The same was true for severe hypoglycemia, pancreatitis, pancreatic tumors and allergic reactions. This answered the two safety questions the FDA had raised for the class. Allergic reactions including anaphylaxis are a listed warning. Most patients develop antibodies to the drug. These can blunt its effect. 12
Liraglutide and semaglutide carry a boxed thyroid C-cell warning. Lixisenatide does not. Its label does report more thyroid C-cell adenomas in two-year studies in mice and rats. No one knows whether that matters for people. Long-term outcome data beyond the two-year ELIXA follow-up are limited. 1
No. Sanofi cited competition and sales. ELIXA and the glucose trials found no safety problem beyond the gut effects common to the class. 23
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Citations
- FDA 2024: Adlyxin (lixisenatide) prescribing information accessdata.fda.gov
- Pfeffer 2015, NEJM: Lixisenatide in patients with type 2 diabetes and acute coronary syndrome (ELIXA) doi.org
- RxLess 2022: Adlyxin will no longer be available in the US rxless.com
Reference information only, not medical advice. Drawn from the Lixisenatide article, fact-checked against the cited sources. No dosing anywhere on this site.