A recent article written by The New York Times addresses an issue that we have been talking about for quite some time, Pradaxa and the bleeding deaths linked to the drug.
Pradaxa is an anticlotting drug that was believed to be better than the decades old warfarin. But, unfortunately the drug has its flaws, and some very dangerous ones at that, as it has been linked with over 500 deaths since its approval just a mere 2 years ago.
Yet it has still become a blockbuster drug, as some had hoped it would, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.
But, how does this happen? How does a drug linked to so many deaths in such a short period of time still reach such financial successes?
In short it’s because it’s maker, along with the FDA, still say that the drug itself outweighs any potential harm it may cause.
The Food and Drug Administration actually just released a report that found that the drug did not show a higher risk of bleeding than for patients taking warfarin. But unlike warfarin, where a patient can take Vitamin K to counteract the bleeding, Pradaxa bleeding has no antidote, and the report did not address this issue.
The drug maker obviously still believes in the drug, but stresses it must be used correctly. “The evolving spontaneous reporting patterns do not indicate a change in the favorable benefit-risk profile of Pradaxa, when used correctly according to the approved label,” Boehringer Ingelheim said in a statement.
In other words, the drug is still safe. But some reports have indicated that doctors are not sufficiently cautious when prescribing Pradaxa, giving the drug to older people or those with kidney problems even though there is evidence that the bleeding risks are higher in those groups. The company recommends testing patients’ kidney function before prescribing Pradaxa and notes that the risk of bleeding increases with age.
Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin.
Critics also say that at least until an antidote is found, better disclosure or more limited use of Pradaxa may be preferable. Patients’ lawyers have begun turning their attention to the drug. More than 100 lawsuits have been filed in federal courts and lawyers say thousands more are expected.
When the F.D.A. approved Pradaxa in October 2010, the drug was hailed as the first in a new category of replacements for warfarin, the nearly 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation.
Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that it is working. Pradaxa required no such monitoring and, compared with warfarin, appeared to be better at preventing strokes.
After approval, sales skyrocketed. By the end of 2011, after just over a year on the market, 17 percent of patients with atrial fibrillation were being prescribed Pradaxa, compared with 44 percent for warfarin, according to a study released in September. About 725,000 patients in the United States have used the drug, according to the F.D.A.[hr]