Anti-Bleeding Drug Used in Military May Pose Risks

<"">NovoSeven, a drug administered to wounded soldiers in Iraq and Afghanistan to stop significant bleeding has been linked to increased risk of heart attacks and strokes.

Drug trials, said the Guardian, reveal that NoroSeven can increase risks for formation of clotting in the arteries, which can lead to deadly complications or complications that mandate amputation. Of note, extensive drug trials have not found NovoSeven to be any better than a placebo for saving wounded soldiers, added the Guardian.

NovoSeven was approved over 10 years ago to stop bleeding in hemophiliacs but has been used off-label by both military physicians and nonmilitary hospitals to stop blood loss due to trauma or surgery, said the Guardian. NovoSeven, also known as recombinant factor seven, runs into the thousands of dollars per patient; however, said the Guardian, a significantly cheaper alternative—tranexamic—costs a fraction of the price, just a few dollars.

As far back as 2006, we were writing about the issues surrounding NovoSeven and its off-label uses. According to the U.S. Food and Drug Administration (FDA) at the time, the medication was linked to heart attacks, strokes, deaths, and other health complications. NovoSeven, manufactured by Danish pharmaceutical company Novo Nordisk, was approved in 1999 after gaining fast-track approval from the FDA. At that time, we wrote that the majority of reported complications associated with the drug involved off-label use.

A Ministry of Defence spokesman confirmed to the Guardian that NovoSeven is used for forces in the United Kingdom as “a medicine of last resort,” when all other attempts to stop bleeding are exhausted, noting that the US military also uses NovoSeven. But, Professor Ian Roberts, a trauma care expert with the London School of Hygiene and Tropical Medicine, issued a warning in 2006 that the drug was being used off-label before drug trials confirmed if the medication does or does not save lives.

“There are both civilian patients and wounded soldiers who will have been given this drug and the best evidence shows they would not have benefited, but would have experienced heart attacks, strokes and possible amputations,” Roberts said, quoted the Guardian. Continuing use of NovoSeven has made the military and hospital surgeons vulnerable, said Roberts, adding, “You cannot defend giving this treatment outside of a randomised controlled trial,” the Guardian quoted.

Roberts has also called for the US military to explain why it is has chosen to use NovoSeven over the past seven years saying, quoted the Guardian, “What advice were they acting on? Was the advice they received truly independent, or were people compromised in any way? It is important to know.”

Dr. Mads Krogsgaard Thomsen, chief science officer at Novo Nordisk, the Danish company that manufactures NovoSeven said, “We cannot encourage as a company, by any means, the off-label use of NovoSeven. This is not something we are promoting and it is not something we are responsible for,” reported the Guardian. Dr. Thomsen believes about 10-to-20 percent of NovoSeven is used off-label.

Help filing claims and other legal assistance for the victims of NovoSeven is available at <"">

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