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The U.S. Food and Drug Administration cast doubt on Wednesday on a possible association of cancer with Sanofi-Aventis' widely used Lantus diabetes drug after recently published studies suggested such a link.
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In a communication posted on its website, the FDA said the duration of patient follow-up in all four studies was shorter than what is necessary to evaluate for cancer risk from drug exposure.
Further, the agency said: "Inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of (Lantus) and cancer truly exists."
The FDA said it was reviewing the safety data for Lantus, including the new studies, to better understand any possible cancer risk.
In the meantime, it urged patients not to stop taking their therapy without talking to their doctors. Sanofi [SNY
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] shares were up 3 percent in Paris.
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