|
Sign In to gain access to subscriptions and/or personal tools.
|
Off-label Reports of New Biologics: Exciting New Therapy or Dubious Research? Examples From Recombinant Activated Factor VII
Walter H. Dzik, MD
Blood Transfusion Service, J-224, Massachusetts General Hospital, Boston, MA 02114sdzik{at}partners.org
References
- Adams C, Young A. Drug-makers’ promotions boost offlabel use by doctors. Knight Ridder Newspapers. Available at: http://www.realcities.com/mld/krwashington/news/special_packages/riskyrx/. Accessed November 3, 2003.
- Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320:79-82.[Abstract/Free Full Text]
- Levi M, Peters M, Buller HR. Efficacy and safety of recombinant factor VIIa for treatment of severe bleeding: a systematic review. Crit Care Med. 2005;33:883-890.[CrossRef][Medline]
[Order article via Infotrieve]
- Grounds RM, Seebach C, Knoth C, et al. Use of recombinant activated factor VII (Novoseven) in trauma and surgery: analysis of outcomes reported to an international registry. J Intensive Care Med. 2006;21:27-39. Accessed May 2005.[Abstract/Free Full Text]
- Wood JJ, O'Connell KA, Wise RP. Post-licensure safety surveillance for recombinant human coagulation factor VIIa. CBER, FDA, Rockville, MD Board Number: H-34. Available at:http://www.accessdata.fda.gov/scripts/oc/scienceforum/sf2005/Search/preview.cfm?abstract_id=62&backto=author. Accessed May 2005.
- Cohen S, Diringer M, Dubois R, et al. Evidence and consensus-based recommendations for the use of recombinant activated human factor VII (rVIIa) therapy. University Health Consortium and Society for the Advancement of Blood Management. Available at: www.uhc.edu. Accessed May 2005.
- Edwards P, Arango M, Balica L, et al. Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months. Lancet. 2005;365:1957-1959.[CrossRef][Medline]
[Order article via Infotrieve]
- Lodge JP, Jonas S, Oussoultzoglou E, et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial. Anesthesiology. 2005;102:269-275.[CrossRef][Medline]
[Order article via Infotrieve]
- Planinsic RM, Testa G, Sukru E, et al. Safety and efficacy of single bolus dose of recombinant factor VIIa in patients undergoing orthotopic liver transplantation: a randomized multi-center study (abstract). Hepatology. 2002;36:660a-660a.[CrossRef]
- Lodge JP, Jonas S, Jones RM, et al. Efficacy and safety of recombinant factor VIIa (rFVIIa) on transfusion reduction in orthotopic liver transplantation (OLT)—a randomized, double-blind, placebo-controlled trial (abstract). Transplantation. 2004;78(suppl 1):93-93.
- Friederich PW, Henny CP, Messelink EJ, et al. Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial. Lancet. 2003;361:201-205.[CrossRef][Medline]
[Order article via Infotrieve]
- Mayer SA, Brun MC, Begtrup K, et al. Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005;352:777-785.[Abstract/Free Full Text]
- Bosch J, Thabut D, Bendtsen F, et al. Recombinant factor VIIa for upper gastrointestinal bleeding in patient with cirrhosis: a randomized, double-blind trial. Gastroenterology. 2004;127:1123-1130.[CrossRef][Medline]
[Order article via Infotrieve]
- Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a doubleblind, randomized, placebo-controlled trial. Br J Anaesth. 2005:94;586-591.[Abstract/Free Full Text]
- Boffard KD, Riou B, Warren B, et al. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebocontrolled, double-blind clinical trials. J Trauma. 2005;59: 8-18.[Medline]
[Order article via Infotrieve]
- Pihusch M, Bacigalupo A, Szer J, et al. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005;3:1935-1944.[CrossRef][Medline]
[Order article via Infotrieve]
- Brown DL, Morgenstern LB. Stopping the bleeding in intracerebral hemorrhage. N Engl J Med. 2005;352:828-830.[Free Full Text]
- Topol EJ. Nesiritide—not verified. N Engl J Med. 2005; 353:113-115.[Free Full Text]
- Blum RS. Legal considerations in off-label medication prescribing. Arch Intern Med. 2002;162:1777-1779.[Free Full Text]
- Reinhardt UE. An information infrastructure for the pharmaceutical market. Health Affairs. 2004;23:107-112.[Abstract/Free Full Text]
- Angell M. The truth about the drug companies. New York, NY: Random House, 2004.
- Mehlman MJ. Off-label prescribing. The doctor will see you now. Available at: http://www.thedoctorwillseeyounow.com/articles/bioethics/offlabel_11. Accessed May 2005.
- Information available at: http://www.phillipsandcohen.com/CM/NewsSettlements/TAP_Oct3_2001.asp. Accessed May 2005.
- Sterns DJ. Re: Lupron® marketing and sales practices litigation. Order granting preliminary approval of settlement, certifying class for purposes of settlement, directing notice to the class and scheduling fairness hearing. US District Court, District of Massachusetts MDL No. 1430 File No 01-CV-10861-RGS. 2004.
- Lenzer J. Pfizer pleads guilty, but drug sales continue to soar. BMJ. 2004;328:1217-1217.[Free Full Text]
Journal of Intensive Care Medicine, Vol. 21, No. 1,
54-59 (2006)
DOI: 10.1177/0885066605285223
 CiteULike  Complore  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter What's this?
This article has been cited by other articles:
|
|
|
|
 
T. E. Macaulay, A. M. Cook, J. L. Fink III, R. P. Rapp, and W. R. Vincent III
Pharmacists' role in facilitating evidence-based prescribing for unlabeled use of medications
Am. J. Health Syst. Pharm.,
October 1, 2009;
66(19):
1735 - 1739.
[Full Text]
[PDF]
|
|
|
|
|
