Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is informing the public that some doctors are worried about the risks associated with Pradaxa. According to Reuters, mounting reports of complications and deaths have some cardiologists questioning whether or not to prescribe the anticoagulant. [http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners idUSBRE85D06G20120614
Pradaxa was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with atrial fibrillation, a condition that causes irregular heart rhythm. According to Reuters, the drug was meant to supersede warfarin, which has been on the market for over 50 years and requires constant monitoring; warfarin patients have to undergo frequent blood testing and restrict aspects of their diet and lifestyle. While these drawbacks do not apply to Pradaxa or its new competitor, Johnson & Johnson’s Xarelto, the drug has its own downsides.
"What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding" said Dr. Sanjay Kaul to Reuters. Dr. Kaul, who is a cardiologist at Cedars-Sinai Medical Center in Los Angeles and also served on independent panels in advising the FDA about Pradaxa and Xarelto, says he has only written one prescription for Pradaxa. There is no antidote to reverse the effects of Pradaxa or Xarelto, meaning there is nothing doctors can do if a patient begins to hemorrhage, outside of dialysis. Despite warfarin’s downsides, it can be effectively reversed with vitamin K.
The lack of a so-called reversal agent means that minor traumas are potentially fatal. This point was emphasized in March by the Journal of Neurosurgery, who published a case report of an elderly Pradaxa patient who suffered a cerebral hemorrhage and died after a ground-level fall in his home. [thejns.org/doi/full/10.3171/2012.2.JNS112132]
Reuters interviewed over a dozen physicians who said that they were concerned about the real-world use of Pradaxa and Xarelto; when not taken properly, the drugs may raise the risk of stroke, serious bleeding and blot clots, especially in patients with impaired renal health.
Dr. Alan Jacobson, who is the director of anti-coagualation services at the Veterans Administration (VA) healthcare system located in Loma Linda, California, said to Reuters “The good news is you now have an alternative to warfarin," but when used improperly, “you can kill a patient as easily with the new drug as you could with the old drug.”
The Institute for Safe Medication Practices (ISMP), a non-profit patient safety group, heightened concerns earlier this month when it published its QuarterWatch report for 2011. According to the report, there were more Pradaxa-linked adverse event reports submitted to the FDA than any other drug last year. In fact, the anticoagulant was the top-reported medication in several categories, withs 542 patient deaths, 2,367 reports of hemorrhaging, 291 cases acute renal failure and 644 cases of stroke. [http://www.ismp.org/QuarterWatch/pdfs/2011Q4.pdf]
Last month, preliminary study results presented at the Thrombosis & Hemostasis Summit of North America compared the Pradaxa and warfarin in a real-world setting and found that 11.5 percent of Pradaxa patients discontinued use due to adverse events, compared to 0.88 percent among patients taking warfarin. [http://www.theheart.org/article/1394361.do]
Parker Waichman LLP is offering free lawsuit consultations to victims of Pradaxa bleeding side effects. If you or a loved one took Pradaxa and experienced a life-threatening bleeding event, please contact their office by visiting the firm's Pradaxa traumatic bleeding page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).