title: Fabry disease and treatment with agalsidase alpha: unsuspected cardiac arrhythmia in two heterozygous women. In reference to pharmacovigilance.
abstract: METHODS
  Two women treated with agalsidase alpha for Fabry disease developed severe heart dysfunctions a few months after the beginning of enzyme replacement therapy (ERT). An adverse effect caused by the treatment was suspected; therefore we informed the French pharmacovigilance authorities about these two events.
  
  
  CONCLUSIONS
  Collecting data systematically about adverse effects which might be caused by drugs is essential for orphan diseases in order to detect potential adverse effects which cannot be suspected at first.
authors.affiliation: Department of Clinical Pharmacy, Bichat-Claude Bernard University Hospital (AP-HP), Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Mougenot
authors.forename: Olivier
authors.initials: O
authors.lastname: Lidove
authors.forename: Catherine
authors.initials: C
authors.lastname: Caillaud
authors.forename: Philippe
authors.initials: P
authors.lastname: Arnaud
authors.forename: Thomas
authors.initials: T
authors.lastname: Papo
mesh_terms: D000328:Adult; D001145:Arrhythmias, Cardiac / Q000139:chemically induced*; D004562:Electrocardiography; D000795:Fabry Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007527:Isoenzymes / Q000009:adverse effects / Q000276:immunology; D008875:Middle Aged; D000519:alpha-Galactosidase / Q000009:adverse effects* / Q000276:immunology
chemical_list: D007527:Isoenzymes; D000519:alpha-Galactosidase