Europe wide suspension for Rosiglitazone
The NHS Central Alerting System has issued an alert advising that the European Committee on Medicinal Products for Human Use has recommended the suspension of the marketing authorisations for rosiglitazone (Avandia®, Avandamet®) across the European Union.
The full content of the alert will be available tomorrow but registered users and those who receive CAS alerts by email will be able to access the content now.
Clinicians are advised to put in place a system to ensure that all patients are reviewed and changed to another suitable treatment in line with NICE recommendations. This could be at the next routine appointment, or sooner if this will reduce patient anxiety.
Patients are advised to continue with their treatment but should contact the healthcare professional supervising their diabetic treatment.
Action: Clinicians should be aware of this product withdrawal. Patients being prescribed rosiglitazone should be identified and contacted to discuss any necessary changes to treatment.
Update: The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) websites both now contain infomation about the recommendation for the withdrawal.
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[...] Se veía venir y al final se ha cumplido la amenaza. La EMA (Agencia Europea de Medicamentos) ha dictado sentencia y el veredicto es contrario a la rosiglitazona (Avandia, Avandiamet, Avaglim), que va a ser retirada del mercado. Se basan en el metanálisis publicado este año en el que se advertía de un aumento de riesgo de IAM en los tratados con rosiglitazona. La noticia ha corrido como la pólvora por la red, y podéis encontrar más información en El Comprimido, Hemos leído, Sala de lectura y Prescribing Advice for GP. [...]
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