In the article “Fibrinogen concentrate – a potential universal hemostatic agent”, published in the October 2009 issue of Expert Opinion on Biological Therapy (Expert. Opin. Biol. Ther. (2009) 9(10):1325‐1333), a slight error has been brought to our attention regarding the calculation of the rate of adverse events associated with Haemocomplettan P.
In Section 7.3 (Post-marketing surveillance), the incorrect sentence:
Over this 22-year pharmaco-surveillance period, 1,034,389 g of Haemocomplettan P has been distributed, equaling 258,597 total doses of 4 g each. The manufacturer has received a total of 48 adverse event reports during the time period, which corresponds to one report for every 3414 doses distributed and an incidence rate of adverse events at 0.00029 per dosage.
Should read:
Over this 22-year pharmaco-surveillance period, 1,034,389 g of Haemocomplettan P has been distributed, equaling 258,597 total doses of 4 g each. The manufacturer has received a total of 48 adverse event reports during the time period, which corresponds to one report for every 5387 doses distributed and an incidence rate of adverse events at 0.00019 per dosage.
The same error occurred in a section of Table 2 – “Summary of pasteurized fibrinogen concentrate, Haemocomplettan”. Below is the corrected section of this table:
Clinical efficacy, safety and tolerability
Congenital deficiency of fibrinogen: Pasteurized fibrinogen concentrate reported as effective.
Acquired deficiency of fibrinogen: Early hemostatic intervention with pasteurized fibrinogen concentrate reported to be an effective hemostatic intervention in patients experiencing peri-operative bleeding.
Low frequency of serious adverse events; 0.00019 events per dosage.
Informa Healthcare would like to apologise for any confusion caused.