title: Evaluation of Aryoseven Safety (Recombinant Activated Factor VII) in Patients with Bleeding Disorders (An Observational Post-Marketing Surveillance Study).
abstract: BACKGROUND
  Recombinant activated factor VII induces hemostasis in patients with coagulopathy disorders. AryoSeven™ as a safe Iranian Recombinant activated factor VII has been available on our market. This study was performed to establish the safety of AryoSeven on patients with coagulopathy disorder.
  
  
  METHODS
  This single-center, descriptive, cross sectional study was carried out in Thrombus and Homeostasis Research Center ValiAsr Hospital during 2013-2014. Fifty one patients with bleeding disorders who received at least one dose of Aryoseven were enrolled. Patients' demographic data and adverse effect of drug and reaction related to Aryoseven or previous usage of Recombinant activated FVII were recorded in questionnaires. Finally data were analyzed to compare side effects of Aryoseven and other Recombinant activated FVII brands.
  
  
  RESULTS
  Aryoseven was prescribed for 51 Patients. Of all participants with mean age 57.18+21.38 yr, 31 cases were male and 26 subjects had past history of recombinant activated FVII usage. Glanzman was the most frequent disorder followed by congenital FVII deficiency, hemophilia with inhibitors, factor 5 deficiency, acquired hemophilia, hemophilia A with inhibitor, and hemophilia A or B with inhibitor. The majority of bleeding episodes had occurred in joints. Three patients (5.9%) complained about adverse effects of Aryoseven vs. 11.5 % about adverse effects of other brands. However this difference was not significant, statistically.
  
  
  CONCLUSIONS
  Based on monitor patients closely for any adverse events, we concluded that Aryoseven administration under careful weighing of benefit versus potential harm may comparable with other counterpart drugs.
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Gholamreza
authors: G
authors: Toogeh
authors: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors: Hassan
authors: H
authors: Abolghasemi
authors: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors: Peyman
authors: P
authors: Eshghi
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Mohammadreza
authors: M
authors: Managhchi
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Mohammadreza
authors: M
authors: Shaverdi-Niasari
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Katayoon
authors: K
authors: Karimi
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Samin
authors: S
authors: Roostaei
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran.
authors: Neda
authors: N
authors: Emran
authors: Thromboses Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran; Dept. of Pathology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
authors: Alireza
authors: A
authors: Abdollahi
keywords: Aryoseven; Bleeding disorders; Safety