EMEA tira veralipride sobre los temores de seguridad
La Agencia Europea de Medicamentos (EMEA) ha recomendado que se retiren los medicamentos veralipride para la menopausia.
El Comité de Medicamentos para Uso Humano (CHMP) de la EMEA encontró que los riesgos de veraliprida en el tratamiento de los sofocos asociados con la menopausia en las mujeres son mayores que los beneficios.
Veralipride es un tratamiento relativamente antiguo y se puso a disposición por primera vez en 1979. Actualmente está autorizado como un medicamento recetado en Bélgica, Francia, Italia, Luxemburgo y Portugal, bajo las marcas Agofa-aventis de sanofi-aventis Agreal y Agradil.
"Agreal / Agradil ha contribuido durante más de 20 años al alivio de los síntomas de la menopausia y [seguimos] creyendo que el perfil de riesgo-beneficio de la medicación sigue siendo favorable siempre que se utilice en estricto cumplimiento con las recomendaciones de tratamiento pertinentes. Sanofi-aventis sin embargo, reconoce que los estándares científicos actuales en Europa para la evaluación del beneficio para los perfiles de riesgo de los medicamentos se han vuelto, en términos metodológicos, más estrictos que los que se aplicaron en el pasado ", dijo sanofi aventis en un comunicado.
Velapride es un neuroléptico que actúa bloqueando la actividad de la dopamina. Las razones por las cuales las mujeres tienen sofocos no están claras, pero como la dopamina parece estar involucrada, la veraliprida puede reducir estos síntomas.
Velapride fue retirado del mercado español en junio de 2005, luego de reportes de efectos secundarios graves que afectaron el sistema nervioso. La autoridad reguladora de medicamentos españoles revisó la seguridad y la eficacia de la medicación y decidió que los beneficios superaban los riesgos.
The European Medicines Agency
(EMEA) has recommended that
medicinal products for menopause
drug veralipride should be
withdrawn.
The EMEA's Committee for Medicinal Products
for Human Use (CHMP) found the risks of
veralipride in the treatment of hot flushes
associated with the menopause in women are
greater than the benefits.
Veralipride is a relatively old treatment and was
first made available in 1979. Currently it is
authorised as a prescription medication in
Belgium, France, Italy, Luxembourg and
Portugal, under sanofi-aventis' brand names
Agreal and Agradil.
"Agreal /Agradil has contributed for more than
20 years to the relief of menopausal symptoms
and [we] continue to believe that the benefit-
risk profile of the medication remains
favourable provided it is used in strict
compliance with relevant treatment
recommendations. Sanofi-aventis nevertheless
recognises that current scientific standards in
Europe for the assessment of benefit to risk
profiles of medicines have, in terms of
methodology, become more stringent than those
which have been applied in the past," sanofi
aventis said in a statement.
Velapride is a neuroleptic that works by
blocking the activity of dopamine The reasons
why women have hot flushes is unclear, but
since dopamine seems to be involved,
veralipride can reduce these symptoms.
Velapride was pulled from the Spanish market
in June 2005, following reports of serious side
effects affecting the nervous system. The
Spanish medicines regulatory authority
reviewed the safety and effectiveness of the
medication and decided that the benefits
outweighed the risks.
The assessment
The CHMP assessed all the available data,
including 11 studies involving around 600
women, where veralipride was compared to a
placebo, and two studies with a total of
around 100 women where it was compared
with conjugated oestrogens (the standard
treatment for menopause).
The CHMP found veralipride showed little
effectiveness in reducing the frequency and
intensity of hot flushes; and that use of the
drug can be associated with side effects
such as
depression, anxiety, sleep
disorders, tremor, and tarkive
dyskinesia which can be
irreversible.
http://www.pmlive.com/pharma_news/emea
_pulls_veralipride_over_safety_fears_8733?SQ_ACTION=clear_design_name&full=true
The European Medicines Agency
(EMEA) has recommended that
medicinal products for menopause
drug veralipride should be
withdrawn.
The EMEA's Committee for Medicinal Products
for Human Use (CHMP) found the risks of
veralipride in the treatment of hot flushes
associated with the menopause in women are
greater than the benefits.
Veralipride is a relatively old treatment and was
first made available in 1979. Currently it is
authorised as a prescription medication in
Belgium, France, Italy, Luxembourg and
Portugal, under sanofi-aventis' brand names
Agreal and Agradil.
"Agreal /Agradil has contributed for more than
20 years to the relief of menopausal symptoms
and [we] continue to believe that the benefit-
risk profile of the medication remains
favourable provided it is used in strict
compliance with relevant treatment
recommendations. Sanofi-aventis nevertheless
recognises that current scientific standards in
Europe for the assessment of benefit to risk
profiles of medicines have, in terms of
methodology, become more stringent than those
which have been applied in the past," sanofi
aventis said in a statement.
Velapride is a neuroleptic that works by
blocking the activity of dopamine The reasons
why women have hot flushes is unclear, but
since dopamine seems to be involved,
veralipride can reduce these symptoms.
Velapride was pulled from the Spanish market
in June 2005, following reports of serious side
effects affecting the nervous system. The
Spanish medicines regulatory authority
reviewed the safety and effectiveness of the
medication and decided that the benefits
outweighed the risks.
The assessment
The CHMP assessed all the available data,
including 11 studies involving around 600
women, where veralipride was compared to a
placebo, and two studies with a total of
around 100 women where it was compared
with conjugated oestrogens (the standard
treatment for menopause).
The CHMP found veralipride showed little
effectiveness in reducing the frequency and
intensity of hot flushes; and that use of the
drug can be associated with side effects
such as
depression, anxiety, sleep
disorders, tremor, and tarkive
dyskinesia which can be
irreversible.
http://www.pmlive.com/pharma_news/emea
_pulls_veralipride_over_safety_fears_8733?SQ_ACTION=clear_design_name&full=true
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