Safety Alerts & Recalls

What does this mean?

As indicated in our alert yesterday, the risk of cancer associated with Insulin Glargine is not well defined and needs additional research. Until additional research information is available, you may want to follow up with your doctor to review your treatment with Insulin Glargine if you already have a cancer, or if you are a woman with a family history of breast cancer.

If you are taking Insulin Glargine, it is important for you to continue with this insulin therapy, especially if you have found it helpful in the management of your diabetes. You should not make any changes to your insulin treatment without first consulting your own doctor.

FDA Early Communication About Safety of Lantus (Insulin Glargine)

Following on from the Lantus (insulin glargine) safety alert we sent yesterday, today the FDA issued a Medwatch Alert in response to the use of Lantus and the possible risk for cancer in patients with diabetes.

FDA is currently reviewing many sources of safety data for Lantus to better understand the risk, if any, for cancer associated with use of Lantus. Discussions are also ongoing between the 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. The FDA will communicate the results for its ongoing review to the public as the review continues.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-07-01
Last Updated: 2009-12-05

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