Pradaxa (dabigatran) and Increased Risk of Heart Attack or Serious Bleeding

Pradaxa ImageWe have been receiving emails and comments from patients concerned about the prescription blood thinner drug Pradaxa, asking if it has been recalled because it was linked to an increased risk of heart attack and serious bleeding events. As of this date, Pradaxa has not been recalled. Continue reading for more information on the potential health risks of this drug.

Pradaxa, also known as Dabigatran, manufactured by Boehringer Ingelheim Pharmaceuticals out of Ridgefield, CT, is a “blood thinner” medication prescribed to patients to help prevent serious blood clots and strokes for people who have Atrial Fibrillation (irregular heartbeats).

Pradaxa is in pill form and can be taken with or without food and should be taken on a set daily schedule.

Health Concerns:  Pradaxa can cause internal bleeding and, in some cases, may lead to death (1. It has also been linked to an increased risk of heart attack (2.  People with the following health related issues may have a higher risk of bleeding from Pradaxa:

  • Aged 75 years or older
  • Have Stomach or Intestine bleeding
  • Take other blood thinning medications or aspirin products
  • Have kidney problems

Some symptoms and adverse reactions to Pradaxa could include:

  • Severe or uncontrollable bleeding
  • Increased risk of heart attack
  • Vomiting or couching blood
  • Dark urine or stool
  • Feeling dizzy or weak

Consult your doctor before taking any prescription medications or if you feel like you are having an adverse reaction to a medication. Do not stop taking Pradaxa (dabigatran) without first consulting with your doctor, as the FDA “continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.” (source)

If there ever is a Pradaxa recall we will publish it as part of our ongoing drug recall alerts.

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Everett Sizemore is the owner and Editor of US Recall News: He is dedicated to educating people about consumer safety, social activism and corporate responsibility by bringing information to Americans about the products they use every day.

2 thoughts on “Pradaxa (dabigatran) and Increased Risk of Heart Attack or Serious Bleeding

  1. I have been on Pradaxa for 9 months after a successful cardioversion for Atrial flutter. I am otherwise quite healthy at 68 years. The regimen calls for 150 mg of Pradaxa b.i.d. I have had no previous cardio issues or diagnosis.

    I can report no negative effects, particularly in bleeding during this period. I recently went to Italy on business, then after a two day turn-around went to Las Vegas for same. Even under these stressful conditions there was no indication of negative effects (ekg clean).

    I might add here that I have been tracking Pradaxa and the only mention of M.I. or serious bleeding is in those people who are over 80 years and having been compromised by lengthy cardio issues. There are sufficient studies to support this statement if only one will take time to research.

    I do, however, see the legal predators running for what they hope will be the money-river which is the usual norm for a new drug.

    I should also add here that I am an active journalist and am always looking for a story. The only one here is that Pradaxa should be allowed to be administered without intervention.

    Clearly, the legal community would do anything to cause a red flag. Sorry guys, not this time; the positive elements far outway the negatives and I would be glad to meet you in court anyday – bring it on!


    • Hello Edgar,

      Thank you for your input on your experiences with Pradaxa. It often seems like the only time people are motivated enough to write a comment on this website or any other is when something has gone wrong – in the same way that people only call customer service when they have a complaint. It is refreshing to read something positive by someone who, ostensibly, has nothing to gain from sharing their experience. Thank you for that.

      While it is true that the legal community jumps at the chance to take advantage of drug recalls and anything that might make a potential nationwide lawsuit, it is also true that drug companies and medical device manufacturers have consistently mislead, lied to or withheld facts from the public concerning reports of adverse events. It is also true that profit is the primary motivator in most industries today, the legal and pharmaceutical industries not withstanding. Personal injury lawyers will not take a case if they don’t think there was some serious negligence involved. If and when you start seeing law firms advertise seeking people who were injured by a certain drug, you can bet they have, or at least think they have, enough evidence to take it to court or force a settlement out of the responsible party. And you can bet that there are hundreds or thousands of plaintiffs who have, and may still be, suffering as a result of the company’s negligence… at least that’s how they see it.

      While it’s easy to blame the legal community for making a big fuss about nothing, it is also easy to forget that with our government doing such a terrible job of policing industry these days the only thing keeping a profit-motivated corporation from harming people is the civil courtroom. Even public opinion matters less and less when a company can just file for bankruptcy, re-brand and start doing it all over again as a “new” company. Just look at the cribs being sold in every major box store in the country. The companies making those have been doing exactly that for as long as I’ve been running this website. And they’ll keep doing it too because they’re obviously finding it profitable, despite the threat of lawsuits and whatever measly power the CPSC has over their practices.

      If you would like to use your journalistic craftsmanship to educate consumers about “the other side” of any story on this site, we invite you to do so. However, our job is to inform consumers about recalls and products that could potentially be recalled soon. We hope this is done in an unbiased fashion. If not, that’s what the comments are for. So thank you for adding yours and providing another side to the story – or, rather, lack of a story.

      – U.S.R.N. Staff

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