Post‐authorization safety study of Clottafact ® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study

Background and Objectives A new fibrinogen concentrate Clottafact ® was developed according to European guidelines on plasma‐derived products. A post‐authorization safety study was set up in 2009 as part of the risk management plan. This was a non‐interventional, prospective, non‐comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real‐life medical practice in France. Materials and Methods The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on‐demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. Results Fourteen patients [1–78 years] were included in 7 centres and followed for 1 year. Twenty‐one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on‐demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. Conclusion This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable.