Insulin Glargine (Lantus) - Risk of Cancer
July 1, 2009
FDA has sent out an early communication to consumers and healthcare professionals regarding four recently published observational trials about Lantus (insulin glargine) and a potential increased risk of cancer. Three of these trials suggest an increased cancer risk. However, there are limitations associated with these trials (eg, inconsistencies between study results, differences in baseline characteristics, and short duration of follow-up) and results do not necessarily show causality.
FDA advises consumers to continue their current insulin therapy. Patients should speak with their healthcare provider if they have questions or concerns about taking insulin glargine.
FDA will continue to review all available safety information with insulin glargine to determine if there is a risk of cancer associated with insulin glargine use. FDA urges patients and healthcare professionals to report adverse events related to insulin glargine use to the MedWatch Adverse Event Reporting program. This can be done online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088.
Additional information is available at the following links:
- MedWatch Alerts
- Early Communication About Safety of Lantus (insulin glargine)
July 1, 2009. University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.