A retrospective survey on the safety of Replenate®, a high-purity factor VIII concentrate

Pharmacoepidemiology and Drug Safety

Volumn 13, Issue 4, 2004, Pages 243-252

  Gascoigne, Ernie W ^a   Dash, C H ^a   Harman, C ^a   Wilmot, D ^a  

^a BIO PRODUCTS LABORATORY   (United Kingdom)

Author keywords

Blood products; Factor VIII; Haemophilia A; Pharmacovigilance

Indexed keywords

ANTIRETROVIRUS AGENT; BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8 CONCENTRATE; BLOOD CLOTTING FACTOR 8 CRYOPRECIPITATE; BLOOD CLOTTING FACTOR 8 DERIVATIVE; BLOOD CLOTTING FACTOR 8 INHIBITOR; COTRIMOXAZOLE; FRESH FROZEN PLASMA; HEPATITIS A ANTIBODY; HEPATITIS A VACCINE; HEPATITIS B CORE ANTIBODY; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B VACCINE; HEPATITIS C ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; REPLENATE; STEROID; VIRUS ANTIBODY;

ADOLESCENT; ADULT; AGED; ARTICLE; BODY WEIGHT; BRAIN HEMORRHAGE; CHILD; CLINICAL PRACTICE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVALESCENCE; DATA ANALYSIS; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG INDUSTRY; DRUG MARKETING; DRUG PURITY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG USE; FEMALE; HEADACHE; HEALTH CARE FACILITY; HEMOPHILIA A; HEPATITIS A; HEPATITIS B; HEPATITIS C VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFLAMMATION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; PARVOVIRUS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHLEBITIS; POPULATION RESEARCH; PRACTICE GUIDELINE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SIDE EFFECT; SKIN IRRITATION; SORE THROAT; SURGICAL TECHNIQUE; TOOTH EXTRACTION; UNITED KINGDOM; VEIN DISEASE; VIRUS TRANSMISSION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; COLECTOMY; CRANIOTOMY; CROSS-SECTIONAL STUDIES; FACTOR VIII; FEMALE; HEPATITIS VIRUSES; HUMANS; LAPAROTOMY; MALE; MIDDLE AGED; QUESTIONNAIRES; RETROSPECTIVE STUDIES; SAFETY;

EID: 1942455726     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/pds.956     Document Type: Article

References (15)

1. Mannucci PM. Outbreak of hepatitis A among Italian patients with haemophilia. Lancet 1992; 339: 819.
2. Peerlinck K, Vermylen J. Acute hepatitis A in haemophiliacs. Lancet 1993; 340: 179.
3. Peerlinck K, Arnout J, Giambattista MD, Gilles JG, Laub R, Jacquemin M, Saint-Remy JMR, Vermylen J. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 1997; 77: 80-86.
4. Shopnick RI, Brettler DB, Bolivar E. Hepatitis C virus transmission by monoclonal-purified viral-attenuated factor VIII concentrate. Lancet 1995; 346: 645.
5. Schulman S, Lindgren AC, Petrini P, Allander T. Transmission of hepatitis C with pasteurised factor VIII. Lancet 1992; 340: 305-306.
6. Gascoigne EW, Dash CH, Harman C, Wilmot D. A new approach to pharmacovigilance in haemophilia: experience with Replenine, a high-purity factor IX concentrate. Pharmacoepidemiol Drug Safe 2004; 13: 187-195.
7. Medicines Control Agency, Committee on Safety of Medicines, Royal College of General Practitioners, British Medical Association and Association of the British Pharmaceutical Industry. Guidelines for company sponsored safety assessment of marketed medicines. Br J Clin Pharmacol 1994; 38: 93-97.
8. Addiego JE, Gomperts E, Liu SK, Bailey P, Courter SG, Lee ML, Neslund GG, Kindon HS, Griffith MJ. Treatment of haemophilia A with a highly purified factor VIII concentrate prepared by anti-FVIIIc immunoaffinity chromatography. Thromb Haemost 1992; 67: 19-27.
9. Horowitz B, Prince AM, Hamman J, Watlevicz C. Viral safety of solvent/detergent-treated blood products. Blood Coag Fibrinolysis 1994; 5(Suppl. 3): S21-S28.
10. UK Haemophilia Centre Directors Organisation. Report on the Annual Returns for 1996. UKHCDO: Oxford, UK, 1998.
11. Snape TJ, Harman C, Sims GEC, Giangrande P, Lee C, Dasani H. Assessment of the potency of factor VIII concentrates. Haemophilia 1996; 2(Suppl. 1): 22 (abstract 82).
12. Morrfini M, Longo G, Messori A, Lee M, White G, Mannucci P, the Recombinate Study Group. Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). Thromb Haemost 1992; 68: 433-435.
13. Kasper CK, Kim HC, Gomperts ED, et al. In vivo recovery and survival of monoclonal-antibody-purified factor VIII concentrates. Thromb Haemost 1991; 66: 730-733.
14. Lusher JM, Hillman-Wiseman C, Hurst D. In vivo recovery with products of very high purity-assay discrepancies. Haemophilia 1998; 4: 641-645.
15. Lusher JM, Salzman PM, the Monoclate Study Group. Viral safety and inhibitor development associated with factor VIIIc ultra-purified from plasma in hemophiliacs previously unexposed to factor VIIIc concentrates. Sem Hematol 1990; 27(Suppl. 2): 1-7.