Dabigatran

To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,¹ which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al² found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.³ Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.

Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.

To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,¹ which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al² found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.³ Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.

Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.

To the Editor: In their response to a letter to the editor (December 2011), Drs. Wartak and Bartholomew suggested the use of recombinant activated factor VIIa (NovoSeven) for bleeding in patients on dabigatran. They based this recommendation on a review by Stangier and Clemens,¹ which was based on phase II and III data on the efficacy and safety of dabigatran. There have been no controlled trials or prospective data on the use of this agent for this indication, nor are there data on its use in bleeding after intracranial hemorrhage, bleeding related to cardiac surgery, or trauma-related bleeding. In a systematic review, Yank et al² found that there is no lower mortality rate and an increased risk of thromboembolism when activated factor VIIa is used off-label. This agent is approved for use only in patients with hemophilia, and in fact Novo Nordisk paid a $25 million settlement for off-label promotion of this drug for nonapproved indications.³ Recombinant factor VIIa costs up to $10,000 per vial, and if it is used off-label, that cost is not reimbursed to the hospital.

Just because we can do something does not mean that we should do it. The use of recombinant factor VIIa for dabigatran-related bleeding needs to be studied in a controlled trial before it is routinely used. As seen in the cited review, indication drift can lead to adverse patient outcomes and will certainly lead to financial peril in hospitals across the country.