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Report raises concerns on the safety of anticlot drug

CHICAGO -- A hemophilia drug has been linked to deaths, strokes, heart attacks, and other complications in patients given the medicine for other types of out-of-control bleeding, such as cerebral hemorrhages, according to FDA researchers.

The medicine, NovoSeven, is a clotting drug that was introduced in 1999 after being approved by the Food and Drug Administration to stop bleeding in hemophiliacs. But it has also shown promise in treating cerebral hemorrhages, a potentially lethal type of stroke involving bleeding in the brain.

Most of the reported complications followed off-label use -- that is, uses for which the drug was not specifically approved by the FDA.

The report appears in today's Journal of the American Medical Association.

The authors, including Dr. Kathryn O'Connell of the FDA's Center for Biologics Evaluation and Research, called for rigorous safety studies of new uses for the drug, which is made by the Danish company Novo Nordisk.

NovoSeven got fast-track approval as an orphan drug, which means the company received financial incentives to develop it because it treats a rare condition and was seen as having little potential for profit.

The company said in a statement that the off-label use of NovoSeven has resulted in complications in older people and those with underlying heart disease and acute injuries. The risk for approved uses ''is thought to be low," the company said.

The company changed the warning in the package insert in October to include information on the side effects in patients without hemophilia. Novo Nordisk said it is conducting studies on the safety of NovoSeven in such patients.

The researchers analyzed 431 reports to the FDA of adverse events, ranging from nausea to death, during the first five years of the drug's use.

In 185 cases, the drug's clotting action may have led to problems such as strokes and heart attacks, according to the study. Most of those problems followed off-label uses and happened within 24 hours of the last dose.

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