title: Post-authorization safety study of Clottafact®, a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable.
authors: Edouard Herriot Hospital, Lyon, France.
authors: C
authors: C
authors: Négrier
authors: Hemophilia Centre, Necker Enfants Malades University Hospital - APHP Paris, Paris, France.
authors: C
authors: C
authors: Rothschild
authors: Charles Nicolle Hospital, Rouen, France.
authors: J-Y
authors: JY
authors: Borg
authors: Bicêtre Hospital, Kremlin Bicêtre, France.
authors: T
authors: T
authors: Lambert
authors: Purpan Hospital, Toulouse, France.
authors: S
authors: S
authors: Claeyssens
authors: Saint-Jean Hospital, Perpignan, France.
authors: L
authors: L
authors: Sanhes
authors: Cochin Hospital, Paris, France.
authors: N
authors: N
authors: Stieltjes
authors: Medical Affairs, LFB Biomédicaments, Les Ulis, France.
authors: A
authors: A
authors: Bertrand
authors: Medical Affairs, LFB Biomédicaments, Les Ulis, France.
authors: M-H
authors: MH
authors: André
authors: Rangueil Hospital, Toulouse, France.
authors: P
authors: P
authors: Sié
authors: Trousseau Hospital, Tours, France.
authors: Y
authors: Y
authors: Gruel
authors: Medical Affairs, LFB Biomédicaments, Les Ulis, France.
authors: Z
authors: Z
authors: Tellier
mesh_terms: D000293:Adolescent; D000328:Adult; D000347:Afibrinogenemia / Q000188:drug therapy*; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005340:Fibrinogen / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003029:Coagulants; D005340:Fibrinogen
keywords: congenital fibrinogen deficiency; fibrinogen concentrate; non-interventional study; post-authorization safety study