Safety Alerts & Recalls
What does this mean?
At this time, the FDA has not concluded that Lantus increases the risk of cancer. The Agency is continuing to review this safety concern and will update the public when additional information is available. If you take Lantus, you should continue to take your Lantus as directed by your doctor or other healthcare provider. Please talk to your doctor or other healthcare provider if you have concerns about Lantus.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of Lantus to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
The FDA Issues Drug Safety Communication: Update to Ongoing Safety Review of Lantus (Insulin Glargine) and Possible Risk of Cancer
The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine). Lantus is a long-acting modified version of human insulin (insulin analog) used to control blood sugar in patients with Type 1 and Type 2 diabetes.
In July 2009, the FDA issued an Early Communication About Safety of Lantus (insulin glargine) to inform the public that it was reviewing four published observational studies, three of which suggested an increased risk of cancer associated with the use of Lantus. The FDA has reviewed all the available data and has determined that a conclusion could not be made based on study results, due to issues with how the studies were designed and conducted.
The FDA is continuing to work with the manufacturer of Lantus and researchers to further evaluate the long-term risk, if any, for cancer associated with the use of Lantus.
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