The FDA ( Food and Drug Administration ) 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.

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. Patients should also contact their healthcare professional if they have concerns about the medicines they are taking.

Similar to human Insulin, Insulin glargine is used to control blood sugar in people with Type 1 and Type 2 diabetes. Insulin glargine, however, is a modified version of human Insulin ( an Insulin analogue ) that allows for the control of blood sugar for extended periods of time ( a long-acting insulin ). Insulin glargine is approved for once-a-day dosage by subcutaneous injection.

The four observational studies evaluated large patient databases and all reported some level of association between the use of Insulin glargine, and other Insulin products, and various types of cancer. The duration of patient follow-up in all four studies was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure. Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of Insulin glargine and cancer truly exists. Additionally, differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk.

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.

Source: FDA, 2009

XagenaMedicine2009


Link: Xapedia - Medical Encyclopedia