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.
Notes
1. More information is available in
a question-and-answer document.
2. Three angiotensin II receptor antagonists are currently available in
centrally authorised medicines: irbesartan, telmisartan and valsartan.
3. Centrally authorised medicines containing Irbesartan are Aprovel,
Karvea, Irbesartan BMS and Irbesartan Winthrop. Irbesartan is also
available in combination with hydrochlorothiazide in the following
centrally authorised medicines: Coaprovel, Karvezide, Irbesartan
Hydrochlorothiazide BMS and Irbesartan Hydrochlorothiazide Winthrop.
4. Centrally authorised medicines containing telmisartan are Micardis,
Pritor and Kinzalmono. Telmisartan is also available in combination with
hydrochlorothiazide in the following centrally authorised medicines:
MicardisPlus, PritorPlus and Kinzalkomb.
5. Valsartan is available in combination with amlodipine in the
following centrally authorised medicines: Exforge, Copalia, Dafiro and
Imprida.
European Medicines Agency
View drug information on Micardis HCT.