The off-label usage of a drug that treats bleeding in hemophiliacs has been linked to deaths, strokes, heart attacks, and other complications, according to the Food and Drug Administration (FDA).
NovoSeven was approved by the FDA in 1999 as a clotting drug for use in hemophiliacs. Later the drug showed potential for treating cerebral hemorrhages, a serious stroke that causes bleeding in the brain, but NovoSeven was not approved by the FDA to treat this type of condition.
Novo Nordisk, makers of the drug, say off-label use of NovoSeven has affected older people and those with underlying heart disease. The risk for FDA approved use of the drug for hemophiliacs is said to be low.
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