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Cardiovascular disorders A review vilafinil of the MAH’s pharmacovigilance database identified 873 spontaneous reports of cardiovascular disorders, of which 171 were serious and 17 had a fatal outcome .
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Positive de-challenge and/or re-challenge was reported in some vilafinil cases .
In the placebo controlled studies, various cardiovascular events occurred almost exclusively in the modafinil vilafinil treated group .
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A fatal outcome was reported in 3 cases (cardiomyopathy, cardiac failure It is noted that in a number of cases leading to discontinuation there was a very tight temporal association between modafinil and the events, and vilafinil that in many cases the patients were young and had no known risk factors .
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