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From the FDA: Lantus (insulin glargine) and Cancer

Posted Jul 02 2009 4:35pm

A friend from the Indian community sent this to me this morning. It's worth knowing about.

Lantus (insulin glargine)

Audience - Diabetes health care professionals, patients

FDA notified health care 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 health care professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program.

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