03/13/2012 // Dallas, Texas, United States // kayvanwey // Kay Van Wey, Attorney at Law
Introduced by Boehringer Ingelheim as a state-of-the-art anticoagulant, Pradaxa is expected to replace Warfarin and has already generated an estimated 1.1 million prescriptions. But just a year after being approved for sale on the U.S. market, health officials have reported that 120 U.S. patients have died after suffering major bleeding events while on Pradaxa.
Pradaxa has been approved to treat atrial fibrillation and is marketed as a safer alternative to Warfarin because it does not require the extensive blood tests Warfarin does. With Warfarin, doctors have to frequently draw patients’ blood to determine the correct dosage of the medication, but Pradaxa does not require this testing, so doctors are not monitoring their patients as closely. This is especially troublesome because Pradaxa has no known antidote. An estimated 260 patients around the world have suffered major bleeding events while on Pradaxa and died as a result. Doctors have reported seeing Pradaxa patients in emergency rooms bleed to death because the doctors could not reverse Pradaxa’s powerful blood thinning effects.
Boehringer Ingelheim first reported in November 2011 only 50 Pradaxa related deaths. When the German drug company later admitted the number of deaths was as high as 260, it said that the previous report was a “reasonable order of magnitude.”
A pre-market approval study conducted on Pradaxa produced favorable results for Boehringer Ingelheim, which supplied the study with a grant. But a correction later issued in the New England Journal of Medicine admitted that an additional 81 adverse events occurred in 80 of the 18,000 patients studied, and 69 of those events were major hemorrhages. Since Pradaxa was approved in October 2010, Boehringer Ingelheim has spent millions in direct-to-consumer advertising.
The U.S. Food and Drug Administration (FDA) announced in December 2011 that it would be investigating serious bleeding events and deaths in patients who took Pradaxa. Both Japan and Australia have already issued safety warnings about the risk of excessive bleeding while on Pradaxa. While U.S. patients wait for the FDA to determine the safety of Pradaxa, how many more will continue to suffer major bleeding events and die?
The FDA has not given consumers a timeline for when its decision on Pradaxa will be released. Meanwhile, Boehringer Ingelheim continues to make millions on a drug of very questionable safety and has yet to provide an antidote.
As the FDA studies Pradaxa’s side effects, trial lawyers across the nation are working to protect consumers by holding Boehringer Ingelheim accountable for the harm Pradaxa has already caused. While the FDA lingers on studies, Pradaxa lawsuits are being filed across the country to get to the bottom of what Boehringer Ingelheim knew about the side effects of Pradaxa and why Pradaxa was approved so quickly.
For more information on Pradaxa side effects, visit www.vanweylaw.com. Van Wey Law will continue to monitor Pradaxa bleeding events and post the latest Pradaxa lawsuit news on www.vanweylaw.com and www.pillmilllmonitor.com.
The pharmaceutical industry is a multi-billion dollar industry that makes its money by selling drugs to consumers that often have dangerous side effects. Dallas drug injury attorney Kay L. Van Wey has written a book for consumers on the secrets of the pharmaceutical industry. Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know is available as a free download at www.vanweylaw.com.
Van Wey Law, PLLC is a personal injury firm located in Dallas, Texas. Lead attorney Kay L. Van Wey is a Board Certified Personal Injury Trial Lawyer with more than 25 years of experience. Ms. Van Wey handles serious personal injury cases, including automobile accidents, wrongful death, dangerous drug and defective product litigation, medical malpractice, and traumatic brain injury claims.
For more information on Pradaxa side effects, visit www.vanweylaw.com.
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