Thursday, July 26, 2012 5:17 PM
|
Venöse Multiple Sklerose, CVI & SVI, CCSVI
Alison Fisher - "The safety of Gilenya has not been specifically studied in patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI), therefore we are unable to provide you further information in this regard."
writes the European Medicines Agency....
(NICE and MHRA have already said it isnt their responsibility.. speak to EMA...)
This is a disaster waiting to happen (though for at least 15 people - the disaster already happened)………………………………………..............................
19 July 2012
EMA/460930/2012
Patient Health Protection
Dear Madam,
Thank you for your query of 6 July 2012 requesting information on the studies of the medicine Gilenya in MS patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI).
The safety of Gilenya has not been specifically studied in patients with Chronic Cerebrospinal Venous Insufficiency (CCSVI), therefore we are unable to provide you further information in this regard.
As referred to in your correspondence, a safety review was recently carried out by the European Medicines Agency. This review was related to cases of death and serious cardiovascular events (problems related to the heart and blood vessels) in patients who had recently started treatment with the medicine, and the product information for Gilenya was subsequently updated to recommend that Gilenya should not be used in patients with a history of cerebrovascular disease. However, if treatment is nonetheless considered necessary, advice from a cardiologist should be sought and an extended monitoring, at least overnight, is recommended after the first dose. For further information, please find below the links to the European Public Assessment Report (EPAR) on this safety review and the Product information:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/002202/WC500129801.pdf http://www.emea.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002202/WC500104528.pdf We hope you find this information useful.
Kind regards,
Rosa
Rosa Gonzalez-Quevedo
Medical Information
European Medicines Agency
7 Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom
info@ema.europa.eu
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/0022 www.ema.europa.eu +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Read carefully, including all the comments & learn more about the Holy Shit:
http://www.facebook.com/notes/alison-fisher/gilenya-and-ccsvi-is-the-emperor-wearing-any-clothes/423743234331897