Pradaxa No. 1 on FDA List of Drugs with ‘Serious Adverse Effects’
The Hasbrook & Hasbrook law firm is providing free legal consultation to people in Oklahoma who have used the prescription drug, Pradaxa, and have experienced severe bleeding. Free consultation is also available to loved ones of Pradaxa patients who have died as a result of severe bleeding.
Pradaxa (dabigatran etexilate) is a blood-thinning drug used to reduce the risk of stroke in people with atrial fibrillation. Atrial fibrillation, an irregular heartbeat, can cause blood to pool in the left atrium of the heart. That pool of blood can form a clot which can travel to the brain and cause a stroke. Pradaxa is an anticoagulant, which reduces the formation of blood clots, thus reducing the incidence of strokes.
The Big Problem with Pradaxa: No Antidote
However, the problem with Pradaxa is that it works too well. When a Pradaxa patient experiences internal bleeding, such as gastrointestinal bleeding or a cerebral hemorrhage, it is difficult and sometimes impossible for physicians to stop the bleeding, due to the drug’s anti-clotting effect.
The FDA received reports during 2011 and 2012 of more than 1,000 Pradaxa patients who died in which Pradaxa was suspected as a cause.
The gaping hole in treatment with Pradaxa is that no antidote exists to counteract its blood-thinning effect. When a Pradaxa patient experiences internal bleeding from which one might otherwise survive, Pradaxa’s anti-clotting effect can cause irreversible bleeding resulting in death.
Since the drug’s FDA approval in October 2010, Pradaxa has been at the top of the FDA list for drugs that have received reports of “serious adverse events.”
- In 2011, the first year after FDA approval, the FDA received 3,781 such reports regarding dabigatran (Pradaxa), including 542 deaths, 2,367 hemorrhages, 644 strokes and 291 acute renal failures.
- In 2012, the FDA received 3,200 such reports, including 582 deaths.
In almost 2,000 Pradaxa lawsuits in the U.S. against the drug’s manufacturer, Boehringer Ingelheim, plaintiffs complain that the German manufacturer did not warn prescribing doctors and prospective patients about the lack of an antidote and the resulting life-threatening inability to reverse the drugs anti-clotting effects.
The many Pradaxa lawsuits contain dramatic accounts of the dangerous and sometimes fatal results experienced by Pradaxa users. Various lawsuits allege:
• A Tennessee woman who began taking Pradaxa to treat her atrial fibrillation died three months later from severe gastrointestinal bleeding.
• A man fell and suffered a fatal brain hemorrhage after a fall. The man was alert and responsive when he was admitted to the hospital, but he fell into a coma within hours and died because physicians could not stop the bleeding in his brain.
• A woman fell and hit her head and died within 24 hours because the doctors could not stop the bleeding in her brain.
• A woman was hospitalized for 12 days due to severe gastrointestinal bleeding, one month after beginning Pradaxa.
Alternative to Warfarin
Pradaxa was developed as an alternative to warfarin, which is sold under the brand names, Coumadin and Jantoven. Warfarin has been in use as a blood-thinning drug for more than 50 years, and it remains by far the most popular anticoagulant on the market, with 33 million prescriptions filled in the U.S. in 2012, compared to 2.2 million for Pradaxa.
Pradaxa is promoted as an improvement over warfarin because it does not require regular blood testing (to see if one’s blood is too thin), nor is there a need to change one’s diet (warfarin users must avoid foods with Vitamin K, which includes many vegetables). Boehringer also claims Pradaxa is more effective than warfarin at reducing the incidence of stroke, although some experts say the difference in effectiveness between the two drugs is marginal.
However, the biggest difference between the two drugs is that warfarin has an antidote. Warfarin’s anti-clotting effect can be counteracted with Vitamin K to stop the bleeding. Considering that huge difference, many plaintiffs and other observers contend that Pradaxa is not a good alternative to warfarin and should not have been approved by the FDA until an antidote was developed.
Boehringer is still not saying much about the lack of a Pradaxa antidote. At the time this web page was written (December 2013), Pradaxa.com’s “Important Safety Information” makes no mention of the lack of an antidote. There are a few references to the lack of an antidote elsewhere on the website, but those are found in information about responding to a Pradaxa overdose, not a warning about the possibility of severe, irreversible bleeding.
After gaining FDA approval for Pradaxa in October 2010, Boehringer Ingelheim spent $464 million in 2011 to advertise and otherwise promote the drug. Boehringer had Pradaxa sales of $829 million in 2011 and more than $1 billion in 2012.
In the many lawsuits against Boehringer, plaintiffs allege that:
• Boehringer marketed Pradaxa as safer than warfarin, when it is not, especially in light of the lack of an antidote.
• Boehringer should not have introduced Pradaxa on the market until an antidote had been developed.
• Boehringer failed to warn prescribing doctors and prospective patients about the possibility of serious, excessive, irreversible and sometimes fatal bleeding caused by Pradaxa.
• Boehringer failed to warn about the possibility of gastrointestinal bleeding, especially among patients who have gastrointestinal issues.
There are 1,748 federal lawsuits pending in the U.S. against Boehringer Ingelheim, according to a Nov. 18 report of the Judicial Panel on Multidistrict Litigation (MDL). All federal cases have been consolidated in the U.S. District Court of the Southern District of Illinois, under U.S. District Judge David Herndon. Herndon has scheduled five “bellwether trials” for August 2014, September 2014, November 2014, January 2015 and February 2015.
In addition to the federal cases, several cases against Boehringer are pending in state courts, including courts in Delaware, California, Connecticut and Illinois.
Our Attorneys can Help if You Were Hurt by Pradaxa
If you or a loved one has experienced severe problems after using Pradaxa, contact our law office for a free consultation. You may contact Hasbrook and Hasbrook by telephone (866-416-4737), email ([email protected]) or use our website contact form.