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Pradaxa Side Effects

Pradaxa label with side effectsMarketed as a superior anticoagulant medication to those previously available to the public, Pradaxa (Dabigatran) showed great promise for patients suffering from atrial fibrillation (“AF”).  Pradaxa, is a blood thinner that works by reducing an AF patient’s risks of blood clots and stroke and was released with the expectation that it would require less maintenance than other anti-clotting drugs such as Warfarin and also, would have fewer side effects.  Though in reality, serious Pradaxa problems, including internal bleeding and death, have been reported in alarming numbers since the drug was introduced just a few years ago.

As a result of such widespread reports, the FDA is currently conducting an investigation of the dangers associated with this widely used drug. Researchers are considering gastrointestinal bleeding, brain and kidney hemorrhaging, and cardiac arrest among other life-threatening health consequences.

Side effects of Pradaxa include over 500 reports of death

Shortly following the FDA’s approval of Pradaxa back in October of 2010, there were over 500 reports of death and several hundred injuries connected with the use of the drug.  Those reports notwithstanding, by August of 2012, nearly 4 million Americans were prescribed Pradaxa, generating yearly sales of more than $10 billion in the U.S. alone.

Pradaxa side effects can be life-threatening and include:

  • Internal bleeding
  • Heart attack
  • Renal failure
  • Stroke
  • Death

Within just two years of its release, Pradaxa has been the subject of numerous lawsuits filed against its manufacturer, Boehringer Ingelheim GmbH (“Boehringer”). Complaints filed against the company contain allegations that Boehringer did not adequately warn the public or medical professionals about serious Pradaxa side effects, especially given the irreversible nature of an internal bleeding event while taking the medication.

Though internal bleeding is a risk commonly associated with anticoagulants, Pradaxa lacks an effective treatment for the internal bleeding it causes.  Patients on comparable medication such Warfarin, the industry leader prior to Pradaxa, can be given a dose of Vitamin K to reverse the effects of the medication and any bleeding that may occur. Despite the real and irreparable risk of an internal bleed, Boehringer has no plans to issue a Pradaxa recall. To the contrary, the medication continues to enjoy wide success in both international and domestic markets.

Signs and symptoms of Pradaxa side effects

Early detection of problems can make all the difference between life and death.  As such, patients taking Pradaxa must be extremely sensitive to the warning signs that might reveal a more serious problem.

Symptoms of internal bleeding may include:

  • Unusual bruising
  • Coughing or spitting up blood
  • Vomiting what appears to be coffee grounds
  • Swelling of the extremities
  • Moderate to severe joint pain
  • Headaches, dizziness or generalized weakness

Treatment for the Pradaxa bleeding

Pradaxa works by inhibiting a certain clotting protein in the blood known as thrombin, which is essential to the formation of blood clots.  Therefore patients who experience bleeding while taking the medication have no way to stop it.  Unlike Warfarin patients who may take a dose of Vitamin K to reverse the effect of the drug in their bloodstream, there is no comparable antidote for patients taking Pradaxa.

Despite Boehringer’s claims that the company is working to create an effective antidote, nothing has yet been released. Hence, until such time that an effective counteragent is developed, more and more people will continue to sustain life threatening and sometimes fatal injuries directly linked to their usage of what is considered a life-saving drug.

No plans to issue Pradaxa recall

Within just one year after the release of Pradaxa to the general public, the FDA received hundreds of adverse health reports by Pradaxa patients.  As a result, in December of 2011, the FDA issued a drug safety communication regarding Pradaxa side effects including a warning about the increased risk of stroke, heart attack, and/or death that may follow an irreversible internal bleed.

Shortly thereafter, in January 2012, the FDA required Boehringer to change the drug label to include information regarding the risks of taking Pradaxa, such as bleeding and renal impairment.  However, following the FDA’s review of Pradaxa’s post-marketing complaints in November 2012, the agency nonetheless asserted that the drug is effective to treat AF and is not any riskier than taking other types of anticoagulant drugs such as Warfarin.

Medical researchers warn about the risk of side effects

According to researchers from the University of British Columbia and published in the journal Therapeutics Initiative, Boehringer’s initial clinical trials used to gain FDA approval for the drug contained serious flaws.  The letter also suggested that the company’s own researchers had allowed their own bias to influence its clinical results.

Two more doctors revealed their own concerns in the New England Journal of Medicine; specifically with regard to the underestimation of the risks of Pradaxa side effects by the medical community, as well as a lacking antidote to reverse bleeding.

The Archives of Internal Medicine contained a report about the effects of the drug on an 84-year old patient.  According to the doctors, the woman developed severe rectal bleeding, suffered a heart attack and shortly died thereafter.  Once again, doctors publicly asserted their concerns about major health risks associated with taking Pradaxa, including the fact that there is no “antagonist” available to counteract some of its effects, such as internal hemorrhaging.

Serious Pradaxa problems trigger hundreds of Pradaxa lawsuits

Hundreds of patients and the families of patients who originally sought to benefit from Pradaxa are now filing lawsuits against its manufacturer.   Specifically, claimants are seeking damages for the serious and sometimes fatal injuries that they and/or their loved ones have experienced, especially uncontrollable bleeding episodes.  Generally, the lawsuits assert that Boehringer did not properly warn the public and healthcare professionals about the serious health risks of taking Pradaxa including the fact that there is no antidote to control bleeding caused by the drug.  Many of the lawsuits are built on grounds of wrongful death.

Due to the growing number of lawsuits and the expectation of much more to come in the near future, on August 8, 2012, the United States Judicial Panel on Multidistrict Litigation (“JPML”) ordered the consolidation of all Pradaxa lawsuits to be heard in the Southern District of Illinois.  The consolidated proceedings are being overseen by the Honorable Judge David Herndon.