|
Lantus (insulin glargine)
Audience - Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of Lantus (insulin glargine) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of Lantus. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
FDA is currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues.
The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.
Read the complete MedWatch Safety summary, including a link to the Early Communication and supporting documents, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
