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EMEA pulls veralipride over safety fears

The European Medicines Agency (EMEA) has recommended that medicinal products for menopause drug veralipride should be withdrawn.

The European Medicines Agency (EMEA) has recommended that medicinal products for menopause drug veralipride should be withdrawn.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.

According to an SEC filing dated 31 December 2006, a first test case combining a number of civil claims from people alleging Agreal caused a range of neurological and psychological disorders, was tried in 2006 in Spain; most of the test claims were dismissed and sanofi-aventis was found responsible for three of them and ordered to pay EUR18,000. Sanofi is currently appealing the decision.

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.

30th September 2008

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