The U.S. Food and Drug Administration, or FDA, said Thursday that it is aware of four recently-published observational studies that looked at the use of Lantus, or insulin glargine, and the possible risk for cancer in patients with diabetes. The agency also said that it is currently reviewing many sources of safety data for the drug, but recommended that patients should not stop taking their insulin therapy. Lantus is a modified version of human insulin made by French pharmaceutical company Sanofi-Aventis (SNY).
Meanwhile, in a separate communique, Sanofi-Aventis said that the FDA approved its Multaq 400 mg tablets for patients with atrial fibrillation, or atrial flutter.
Similar to human insulin, insulin glargine is used to control blood sugar in people with Type 1 and Type 2 diabetes. It allows for the control of blood sugar for extended periods of time. Insulin glargine is approved for once-a-day dosage by injection under the skin.
According to FDA, three of the four observational studies on Lantus suggested an increased risk for cancer. FDA is currently reviewing many sources of safety data for Lantus, including the 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.
The four 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 noted.
FDA also said that discussions are ongoing between FDA and the manufacturer of Lantus as to whether any additional studies evaluating the safety and efficacy of the drug will need to be performed. The results of the ongoing review will be communicated to the public as soon as the review is complete.
Further, FDA, based on the currently available data, recommended patients to not stop taking their insulin therapy without consulting a physician, as uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects.
Announcing the FDA's approval of Multaq, Sanofi-Aventis said that Multaq is the first drug approved in the U.S. that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with atrial fibrillation, or AF, or atrial flutter, or AFL.
AF, a potentially life-threatening condition, affects about 2.5 million people in the U.S. and 4.5 million people in the European Union. The FDA approval of Multaq is based on five international, multi-center, randomized clinical trials involving around 6,300 patients, the company noted.
SNY closed Wednesday's trading at $30.34, up $0.85, on a volume of 6.14 million shares.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.