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MAH(s): Almirall, S.A., Temis Farma, S.L., Ivowen Ltd. (Airtal and associated names)
Background
At its September 2013 meeting, the PRAC was notified of the intention of the MAH for the innovator of
the aceclofenac-containing medicines to submit a variation to update the product information regarding
cardiovascular risk, in line with the PRAC recommendations for diclofenac as agreed in PRAC minutes
10-13 June 2013. A proposal for updating the product information was submitted at national level
together with a DHPC and ES requested PRAC advice on this variation and on the related
communication.
Summary of advice
The PRAC provided recommendations for improving the wording of the product information and on the
content of the DHPC.
Post meeting note: upon request of IT PRAC clarified that such recommendations are applicable to all
products containing aceclofenac.
11.1.2. Olmesartan (NAP)
Olmesartan, hydrochlorothiazide (NAP)
PRAC consultation on a variation procedure, upon Germany’s request
Regulatory details:
Lead member: Valerie Strassmann (DE)
Administrative details:
Procedure number(s): DE/H/xxxx/WS/068/G
Procedure scope: Work sharing variation assessing the implementation in the product information of
the PRAC recommendation regarding the risk of cardiovascular mortality in patients with type II
diabetes as well as the PRAC recommendation to include a warning about sprue-like enteropathy in
association with the use of olmesartan
MAH(s): Daiichi Sankyo Europe GmbH (Olmetec and associated names)
Background
Following discussion in 2012 (see PRAC minutes 29-31 October 2012) new information and a recently
published study data had become available on olmesartan and the risk of cardiovascular mortality in
patients with type 2 diabetes. Further information, together with a proposal for updating the product
information, had been submitted by the MAH in the framework of a national work-sharing variation.
The PRAC had also discussed whether a meta-analysis comprising trial data from all ARBs was useful
for a further evaluation of the signal of increased cardiovascular risk at the therapeutic class level.
Summary of advice
The PRAC agreed on the inclusion of a wording reflecting the imbalances in cardiovascular risk as seen
in diabetic patients treated with olmesartan to be added under the ‘pharmacodynamic properties’ in
the product information.
The PRAC also agreed that the recently published epidemiological studies aiming to evaluate the risk of
mortality and cardiovascular endpoints in olmesartan users, as compared to other ARB users, were not
conclusive.
The PRAC therefore agreed that there was still a need to closely monitor the signal of increased risk of
cardiovascular events in diabetic patients to gain further evidence. This should be done within the
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 43/75