[AF] Renelato de estroncio Ef 2ios.

[Mariano Madurga]

Hola a todos:
Además de todo lo comentado por Teresa Y Emilia, y contestando a Francisco,
os puedo comentar que la decisión de Francia ha motivado lo que se llama en
la UE un proceso de revisión o arbitraje (referral) en el seno del Comité
CHMP de la EMA, por el que se están revisando los aspectos de seguridad del
ranelato de estroncio (PROTELOS y OSSEOR).

El proceso se inició en octubre 2011 (ver en:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/10/news_detail_001366.jsp&mid=WC0b01ac058004d5c1)
cuyo texto copio a continuación y se espera que pronto se tendrá una
postura común para toda la Unión Europea:

20/10/2011
European Medicines Agency starts review of Protelos / Osseor

*Evidence relating to cardiovascular and cutaneous toxicity to be
considered again*

The European Medicines Agency has started a review of the
strontium-ranelate-containing osteoporosis medicines Protelos and Osseor,
to determine whether the cases of venous thromboembolism and drug rash with
eosinophilia and systemic symptoms have an impact on their benefit-risk
profile and conditions of use.

Protelos and Osseor, from Les Laboratoires Servier, were authorised via the
centralised procedure on 21 September 2004 and are indicated for treatment
of postmenopausal osteoporosis to reduce the risk of vertebral and hip
fractures.

Venous thromboembolism (VTE) and drug rash with eosinophilia and systemic
symptoms (DRESS) are known risks of these medicines. The risk of VTE was
identified in clinical trials and the risk of DRESS through spontaneous
reporting soon after the granting of the initial marketing authorisation,
and warnings are included in the product information. The risks are
addressed in the risk-management plan and have been kept under close review
by the Agency’s Committee for Medicinal Products for Human Use (CHMP).

A study analysing the side effects associated with strontium ranelate
spontaneously reported in France from January 2006 to March 2009 to Les
Laboratoires Servier or the French competent authority (Afssaps) noted 199
severe adverse reactions, of which 52% were cardiovascular (most frequently
VTE events) and 26% were cutaneous. The authors concluded that DRESS
syndrome is unpredictable, but that the VTE risk could be reduced by adding
a contraindication for patients with a history of VTE and by stopping
treatment if a new VTE risk situation occurs. Based on a recent
pharmacovigilance update and pending an EU-wide review, Afssaps recommended
restricting the use of strontium ranelate to those patients who are under
80 years of age, at high risk of fractures and who cannot take
bisphosphonates.

The CHMP is now reviewing all relevant data on the cardiovascular and
cutaneous safety concerns, taking into account existing risk-minimisation
measures and their impact on the benefit-risk balance for Protelos and
Osseor. The Committee will issue an opinion on measures necessary to ensure
the safe and effective use of these medicines and whether or not the
marketing authorisations for these medicines should be changed, suspended
or revoked.

While this assessment is ongoing no changes to the conditions for use of
Protelos and Osseor are being recommended Europe-wide.


Un abrazo,
Mariano Madurga
AEMPS




> El 24 de febrero de 2012 19:02, Maria Teresa Eyaralar Riera
> escribió:

> Esto es lo que sabíamos