FDA notified healthcare 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 healthcare 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, including a link to the Early Communication and supporting documents, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170089.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

SOURCE: Lantus Attorney › FDA MedWatch Alert: Lantus and Cancer

The FDA, meanwhile, is holding meetings with representatives of Sanofi to determine the need for more research of  Lantus and whether more clinical trials are necessary.

A German study found that of 127,031 diabetes patients using insulin, malignancies were more common in Lantus users than in patients who were treated with natural insulin.

A Swedish study involving 114,841 diabetes patients found that those treated with Lantus were twice as likely to develop breast cancer than subjects treated with regular insulin.

A study conducted in Scotland that monitored 49,197 patients also found a higher rate of cancers among Lantus users, although the difference was considered statistically insignificant.

Only the smallest study, conducted in the U.K. and involving just over 10,000 patients, found no difference in cancer rates between Lantus and non-Lantus users.

The European Association for the Study of Diabetes (EASD) said the studies were “far from conclusive” and necessitated further investigation. EASD President Ulf Smith said in a statement that while there is no direct evidence Lanus causes cancer, the drug may cause already existing cancers to develop and spread more rapidly, as insulin has been demonstrated to do in laboratory cultures.

Similar drugs, such as Levemir, a synthetic insulin produced by Danish company Novo Nordisk, haven’t been on the market long enough to clinically determine their risks. Lantus has been available since 2000.

Dr. Louis Philipson of the University of Chicago Medical Center told Reuters that he has been taking calls from diabetics worried about the latest Lantus news.

“Even though this information is early and the results are conflicting, it’s still the case that using less of this drug is a good idea,” he said.

SOURCE: Lantus Attorney › FDA, EASD concerned about Lantus cancer risk