The FDA is questioning data from four recently published observational studies that suggested a potential link between the use of sanofi-aventis’ Lantus (insulin glargine) and an increased risk of cancer, according to an early communication notice posted Wednesday on the agency’s website.
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“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,” the regulator explained. According to the FDA, three of the four studies suggested an increased risk of cancer with Lantus use. However, the duration of patient follow-up in the four studies, which evaluated large patient databases, “was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure.” In addition, the agency said variations in patient characteristics across the treatment groups could have played a role in the finding of increased cancer risk.
The FDA said it is reviewing various sources of safety data for Lantus “to better understand the risk, if any, for cancer,” and is working with sanofi-aventis to determine whether additional safety or efficacy studies will be needed. The drugmaker commented Wednesday that it was “committed to working with the FDA and other health authorities and scientific experts to clarify the situation.”
In related news, Edwin Gale, editor-in-chief of Diabetologia, which published the studies on June 26, explained that there are concerns that the follow-up period of one and a half years was very short. “Normally cancer studies take five to 10 years so it’s astonishing that there should be a signal within such a short time,” he stated. He also indicated that the journal’s reviewers questioned certain aspects of the studies, including why researchers did not adjust for body mass index as an indication of obesity, which is associated with cancer risk independent of treatment with insulin. He noted that large observational studies are well-known to be difficult to interpret, and require statistical corrections.
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