Pharmacovigilance

Safety of medicinal products containing insulin glargine as active substance

30.06.2009

The European Medicines Agency (EMEA) issued a press release concerning the safety of the medicinal products containing insulin glargine as active substance, in connection with the recently published registry studies investigating a possible relationship between insulin analogues, in particular insulin glargine, and the risk of cancer.

On the basis of the currently available data, a relationship between insulin glargine and cancer cannot be confirmed nor excluded. Further, more detailed assessment of study results and other relevant data needs to be conducted by the EMEA's Committee for Medicinal Products for Human Use (CHMP). Patients being treated with insulin glargine are advised to continue their treatment as normal. In case of any concerns, patients should consult their physician.

The medicinal product Lantus which contains insulin glargine as an active substance is approved for marketing in the Republic of Croatia. The Agency for Medicinal Products and Medical Devices continues to closely monitor the safety of this class of medicines and will inform about the findings of the detailed assessment by the EMEA's Committee for Medicinal Products for Human Use.

In order to see the EMEA's press release, click on the link below:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Lantus/40847409en.pdf

Back