Additional information on safety of medicinal products containing insulin glargine as active substance
24.07.2009
Following review of all available information on a possible relationship between insulin analogues, in particular insulin glargine; and the risk of cancer, European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that available data does not provide a cause for concern and that changes to the prescribing advice are therefore not necessary.
Concerns over a possible relationship between these medicines and cancer, in particular breast cancer, were raised by several recently published registry studies. The Committee carried out an in-depth review of these studies and their outcomes. Due to methodological limitations the studies were found to be inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded. In addition, the Committee noted that the results of the studies were not consistent.
Because of the limitations of the existing evidence, the Committee has requested the marketing authorisation holder to develop a strategy for generation of further research in this area. In addition the Committee is exploring possibilities for cooperation with academia to generate further information. The Agency for Medicinal Products and Medical Devices of the Republic of Croatia will continue to monitor closely the safety of this class of medicines.
EMEA's statement can be found below:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Lantus/47063209en.pdf
The initial information from the ALMP from June 2009 can be viewed using the link below: http://www.halmed.hr/Novosti-i-edukacije/Novosti/2009/Sigurnost-primjene-lijekova-djelatne-tvari-inzulin-glargin/300/
