Research, published in the Nov. 4 issue of the New England Journal of Medicine, reveals that the drug that is initially supposed to stop patients with hemophilia who suffer under additional severe conditions from bleeding, may at the same time cause heart attacks or strokes.
This information is significant for doctors who have to outweigh the two consequences if they are about to decide if a patient should receive the drug called recombinant activated factor VII.
"If you are a physician confronted with a patient with excessive blood loss, and you have done everything you can and this patient is almost dying because of the bleeding, it's quite acceptable to give the drug even if it's associated with a risk of thrombosis [clotting]," said one of the authors of the study. In case, bleeding is not life threatening and can be stopped with help of alternative treatments, the expert does not recommend the drug.
The important study results on the specific drug were made possible by its producer Novo Nordisk, who supported the researchers by giving them complete access to all documents concerning the drug. The company itself has been suspicions about the possible negative side-effects of the drug and wanted to obtain scientific proof.
Involved researchers applaud Novo Nordisk’s move: "It would be really great if other companies would do the same so that clinicians thinking about using it a drug in an off-label setting would have all the information at hand so they could make the right decision, which is benefit vs. risk."
Already ten years ago, the Food and Drug Administration legalized the product on the market as treatment method for injured patients with hemophilia.