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DECISION AGENCIA EUROPEA DEL MEDICAMENTO
QUESTIONS AND ANSWERS ON THE RECOMMENDATION TO WITHDRAW THE


MARKETING AUTHORISATION OF VERALIPRIDE


The European Medicines Agency (EMEA) has completed a review of the safety and effectiveness of


veralipride. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded


that veralipride’s benefits do not outweigh its risks, and that all marketing authorisations for medicines


containing veralipride should be withdrawn throughout Europe. The review was carried out under an


‘Article 31’ referral1.


What is veralipride?


Veralipride is a medicine used to treat hot flushes associated with the menopause in women. It was


first made available in 1979 and is still authorised in Belgium, France, Italy, Luxembourg and


Portugal under the trade names Agreal and Agradil. It is only available with a prescription.


Veralipride is a neuroleptic. It works by blocking the activity of a neurotransmitter called dopamine.


Neurotransmitters are chemicals in the nervous system that allow nerve cells to communicate with


each other. The reasons why women have hot flushes is unclear, but since dopamine seems to be


involved, veralipride can reduce these symptoms.


Why was veralipride reviewed?


Until June 2005, veralipride was also marketed in Spain. Following reports of serious side effects


affecting the nervous system, the Spanish medicines regulatory authority reviewed the safety and


effectiveness of the medicine and concluded that its benefits did not outweigh its risks. The Spanish


authority therefore withdrew veralipride’s marketing authorisation on 27 June 2005, meaning that the


medicine could no longer be sold on the Spanish market. This was followed by a number of regulatory


actions in other countries where veralipride is authorised, including making changes to veralipride’s


product information (the instructions on how a medicine should be used). These changes aimed to


reduce the risk of patients developing side effects.


Consequently, the European Commission asked the CHMP to carry out a full assessment of the


benefit-risk balance of veralipride and to issue an opinion on whether the marketing authorisations for


products containing veralipride should be maintained, varied, suspended or withdrawn across the


European Union.


Which data has the CHMP reviewed?


In this review, the CHMP has assessed all of the available information on the safety and effectiveness


of veralipride. This included 11 studies involving a total of around 600 women, in which veralipride


was compared with placebo (a dummy treatment), and two studies in a total of around 100 women


where it was compared with conjugated oestrogens (a type of hormone replacement therapy [HRT],


the standard treatment for the symptoms of the menopause). The CHMP also looked at other small


studies and reports of side effects from women taking veralipride.





What are the conclusions of the CHMP?


Based on the information available, the CHMP has concluded that:


• Veralipride shows limited effectiveness in reducing the frequency and intensity of hot flushes.


• The use of veralipride can be associated with side effects, including depression, anxiety, sleep


disorders, tremor (shaking) and tardive dyskinesia (an involuntary movement disorder which


may be long-lasting or irreversible). Some of these side effects can occur not only during


treatment, but also after it is stopped. It is also impossible to predict which women may be at


risk.


The CHMP considered restricting the use of veralipride to a maximum of three months. However, it


concluded that the risk of side effects would not be reduced sufficiently by this measure. In addition,


hot flushes usually persist for up to two years.


Therefore, the CHMP concluded that the benefits of veralipride do not outweigh its risks. It


recommended that the marketing authorisation of veralipride be withdrawn and that all veralipridecontaining


medicines be recalled from the European Union markets. It also recommended that the


companies that market these medicines inform all healthcare professionals about the withdrawal


directly.


What are the recommendations for patients and prescribers?


• Patients who are taking veralipride for the treatment of hot flushes should consult their doctors


to discuss what other treatment they can use.


• Prescribers should not issue any new prescriptions for veralipride and should switch patients


currently taking the medicine to an alternative treatment if necessary. Since abrupt


discontinuation of veralipride may lead to symptoms such as anxiety, insomnia (difficulty


sleeping) and depression, prescribers should consider gradually reducing the dose of veralipride


over one to two weeks.


• Patients who have any questions should speak to their doctor or pharmacist.


A European Commission Decision on this opinion will be issued in due course.
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