The European Medicines Agency (EMEA) has recommended that the product information of all centrally authorised angiotensin II receptor antagonists be harmonised, regarding their use during pregnancy. Following a review of the safety of these medicines during pregnancy, the EMEA's Committee for Medicinal Products for Human Use (CHMP), at its April 2008 meeting, recommended that the product information should state that the use of angiotensin II receptor antagonists should be avoided in the first three months of pregnancy. The CHMP also confirmed that angiotensin II receptor antagonists must not be used during the second and the third trimester of pregnancy and that the contraindication already in place should therefore be maintained.
Angiotensin II receptor antagonists are used in the treatment of patients with essential hypertension (high blood pressure that has no identifiable cause).
The CHMP conclusions stem from a safety review conducted by the EMEA's Pharmacovigilance Working Party. This review included also a large number of non-centrally authorised medicines. Implementation of the recommendations for non-centrally authorised medicines will follow through the appropriate national procedures.
For more information, visit:
http://www.emea.europa.eu