Safety of fibrinogen concentrate: analysis of more than 27 years of pharmacovigilance data

Thromb Haemost. 2015 Apr;113(4):759-71. doi: 10.1160/TH14-06-0514. Epub 2014 Dec 11.


Fibrinogen concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of fibrinogen concentrate were distributed over the pharmacovigilance period, corresponding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that fibrinogen concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, fibrinogen concentrate showed a promising safety profile.

Keywords: Fibrinogen; pharmacovigilance; safety.

Publication types

  • Review

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Aged
  • Drug Contamination
  • Drug Hypersensitivity / diagnosis
  • Drug Hypersensitivity / etiology
  • Drug-Related Side Effects and Adverse Reactions / diagnosis
  • Drug-Related Side Effects and Adverse Reactions / etiology*
  • Female
  • Fibrinogen / adverse effects*
  • Hemostatics / adverse effects*
  • Hepatitis B / transmission
  • Hepatitis C / transmission
  • Humans
  • Male
  • Middle Aged
  • Patient Safety
  • Pharmacovigilance*
  • Risk Assessment
  • Risk Factors
  • Thromboembolism / chemically induced
  • Thromboembolism / diagnosis
  • Time Factors
  • Young Adult


  • Hemostatics
  • Fibrinogen