The blood thinner Pradaxa is certainly not a medication you feel tepid about—you either love it or you hate it…or you love it and hate it. Doctors in Kentucky certainly face a dilemma when considering prescribing it to their cardiac patients.
Blood thinners—anticoagulants—are prescribed to patients with cardiac arrhythmia, or irregular heartbeats, to prevent stroke. The medication used for years, warfarin (sold under the brand name Coumadin), comes with its share of problems:
- Many food and drug interactions;
- Frequent blood testing to ensure that the level of warfarin in the blood is correct;
- Increased risk of bleeding, including brain hemorrhages;
- Hereditary resistance to the drug; and
- Change in response to the drug for environmental reasons, such as aging or a change in smoking habit.
When Pradaxa came along in 2010, it was heralded as an enormous improvement over warfarin. There are far fewer food and drug interactions, patients do not have to undergo intensive blood monitoring, and it may be even better than warfarin at preventing stroke. So what’s not to love?
The Monster in the Closet
A year after Pradaxa became available, reports of uncontrollable bleeding began to surface. Unlike warfarin, Pradaxa has no reversal agent: there is no way to stop the bleeding. In 2011, a total of 3,781 adverse effects and 542 deaths associated with Pradaxa use were reported to the Food and Drug Administration (FDA)—more than any other monitored drug.
With millions of people taking Pradaxa twice a day, lawsuits have burgeoned. A judicial panel was organized in Southern Illinois to consolidate all of the Pradaxa cases.
Cardiologists’ reactions to the negative reports vary. Some are now extremely careful about prescribing Pradaxa, while others think that the dangers are exaggerated.
Some Doctors Practice Caution
Dr. Keith Churchwell, executive director of Vanderbilt’s Heart and Vascular Institute, emphasizes that Pradaxa’s therapeutic effects begin sooner than with other drugs. He also points out that Pradaxa requires fewer blood tests and dietary restrictions. He is hesitant to prescribe the drug, however.
“The big reason there’s been a slow response to putting more patients on Pradaxa is because of the significant bleeding. Right now, we don’t have a good mechanism to reverse it,” he said.
Others Remain Optimistic
Dr. George Crossley, medical director of cardiac services at Baptist Hospital in Nashville, said that his team of cardiologists were among the first in the United States to test Pradaxa. He considers the drug a significant improvement over warfarin.
Crossley referred to a study in the New England Journal of Medicine, which stated that Pradaxa is as safe and effective as warfarin. “The data we have is very, very strong,” Crossley said. “For both safety and efficacy, Pradaxa is preferred.”
If Pradaxa turned out to be a curse for you or someone you love in Kentucky, you need the legal services of the Louisville Pradaxa complications lawyers at Gray and White Law. Call us at 502-210-8942 or toll free at 888-450-4456 and set up a FREE, no-obligation consultation.