FDA advisory on Lantus

While the results of several studies in Europe show a link between Lantus and increased cancer risk, FDA tells patients not to stop use

The FDA recently notified health care professionals and patients that it is aware of four 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.

Because the European studies – conducted in Germany, Sweden and Britain – are preliminary, the FDA currently 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.

The 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, Sanofi-Aventis, as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed.

The FDA encourages both health care 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.