Jan
2006

Thromboembolic adverse events after use of recombinant human coagulation factor VIIa.

O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM
JAMA 2006;295(3):293-298.
NATA Rating :
Review by : M. Aldouri
NATA Review

The main adverse effects to be expected from the use of rFVIIa is the occurrence of thromboembolic complications. This study reviews the occurrence of adverse effects reported to the FDA over a period of more than 5 and a half years. A total of 431 reports were found including 185 thromboembolic events in 168 patients. However, relating those to therapy with rFVIIa is hindered by the concomitant medications and existing medical condition, added to the inherent limitations of passive surveillance. The safety and efficacy of rFVIIa can best be assessed in the context of randomized clinical trials.

– Maadh Aldouri