NovoSeven Side Effects Injury Lawsuits. NovoSeven (Generic: Factor vIIa, Recombinant), a hemophilia drug manufactured by Novo Nordisk, has been linked to strokes, heart attacks, deaths and other complications in some patients. NovoSeven was approved as a clotting drug in 1999 to stop bleeding in hemophiliacs. Use of NovoSeven to treat cerebral hemorrhages, a sometimes lethal type of stroke where there is bleeding in the brain, has been off-label. Novo Nordisk has admitted that off-label use of NovoSeven causes complications in certain groups of patients including the elderly, those with underlying heart disease, and those with acute injuries.
NovoSeven Injury Data
In October 2005, the label of NovoSeven was changed to include information on side effects in patients without hemophilia. Recent adverse effect data published in the Journal of the American Medical Association included 431 reports of adverse events ranging from minor to death over the drug’s first five years. According to the research, the drug’s clotting action may have led to strokes, heart attacks and other serious complications in 185 cases. The study found that most of the reported events were with off-label uses and happened within 24 hours of the last dose of NovoSeven.
Increased Off-Label Use
NovoSeven costs $7,500 per dose. Since its approval, it has been used for other uses than hemophilia such as stemming bleeding from surgery, injuries or strokes. Off-label usage of the drug has resulted in an increase in users from 349 patients in 2000 to over 4,500 in 2004. NovoSeven Risks Were Previously Known: A study published in 2005 in the New England Journal of Medicine and funded by Novo Nordisk showed that NovoSeven can help patients with bleeding strokes. That study also found that there were complications including heart attacks and strokes caused by blood clots.