The FDA said it is reviewing the safety of Lantus, an artificial form of insulin which had sales of $3.45 billion in 2008, and is in talks with Sanofi about whether any additional studies need to be conducted to determine the drug's safety since it has a potential link to increased cancer risks.
Despite the concerns, the FDA said patients should continue taking Lantus, a diabetes drug, which is made by Sanofi-Aventis SA's (SNY).The Paris based company said it is committed to working with the FDA to clarify the situation surrounding its artificial form of insulin, Lantus. A company spokesman said Sanofi stands behind the drug's safety.
Studies published Friday in Diabetologia, the journal of the European Association for the Study of Diabetes, showed a possible link between Lantus and cancer. The FDA criticized the studies in an early communication warning posted Wednesday on its Web site.
The agency said the duration of follow-up for patients in the studies was shorter than what is generally considered necessary to evaluate 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," the FDA said, using the scientific name for Lantus.
Europe's drug regulator is also reviewing the studies.
The London-based European Medicines Agency (EMEA) on Monday said the studies into the possible link between insulin analogues and the risk of developing cancer were worthy of more in-depth investigation. The European Union's drug regulator said its Committee for Medicinal Products for Human Use will now carry out a detailed assessment of them.
A co-author on one of the studies, Professor Edwin Gale of Bristol University in England, said the FDA is misinterpreting the point of the information.
"We don't believe that these studies show that insulin turns healthy cells into cancerous cells, which would take much longer to evaluate. But we do believe they are evidence that insulin makes cancers grow more quickly and that this can be evaluated within three years."
We'll be eying these reports for more follow ups.Source
