The EMEA investigated the possibility of a link between insulin glargine use and cancer risk after three studies highlighted safety concerns.
Following a review of the data, the agency's Committee for Medicinal Products for Human Use (CHMP) said: ‘The available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.'
The committee said that methodological limitations meant that the studies were inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded.
The committee has asked Sanofi-Aventis, Lantus's licence-holder, to develop a strategy for conducting further research into the product's safety profile.
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