Study suggests insulin may increase cancer risk; Sanofi-Aventis responds

NEW YORK A popular brand of insulin may increase the risk of cancer, according to a recent study.

The study, conducted by Germany’s Institute for Quality and Efficiency in Health Care and the Wissenschaftliches Institut der AOK, and published in the journal Diabetologia, analyzed data on nearly 130,000 German diabetics from 2001 to 2005 who had received human insulin or the synthetic insulin analogues Lantus, Eli Lilly & Co.’s Humalog (insulin lispro) or Novo Nordisk’s Novorapid (insulin aspart).

The studies found that malignancies occurred more frequently in patients taking Lantus than in those taking human insulin or the other insulin analogues. Still, the researchers who conducted the analysis cautioned against drawing conclusions prematurely. “Our analysis does not provide absolute proof that glargine promotes cancer,” study co-author Peter Sawicki of the Institute for Quality and Efficiency in Health Care stated. “Our study does, however, arouse an urgent suspicion, which should have consequences for the treatment of patients.”

Sanofi-Aventis disputed the findings. “The results of the registry analyses recently published in Diabetologia clearly show that no definitive conclusions can be drawn regarding a possible causal relationship between Lantus use and the occurrence of malignancies, as the authors of the analyses point out,” a company representative told Drug Store News.

A statement by the company also said that clinical studies, which it called the “gold standard of evidence,” did not indicate an association between Lantus and cancer.

The Food and Drug Administration announced that it had become aware of the study and was reviewing multiple sources of safety data on Lantus, including clinical trial data, but recommended that patients currently using the drug not stop taking it until they have consulted their physicians.