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Pradaxa

Pradaxa is a prescription blood thinner. People use Pradaxa to lower the chance of stroke and blood clots. The U.S. Food and Drug Administration warns that suddenly stopping Pradaxa or missing doses may increase the risk of blood clots or stroke. This can cause permanent disability and death. Pradaxa can also cause drug interactions if taken at the same time as certain medications. Side effects of Pradaxa include serious and sometimes fatal bleeding. The FDA gave full approval to a Pradaxa bleeding antidote in April 2018. Boehringer Ingelheim makes Pradaxa. The company recalled a batch of Pradaxa in 2012, citing a potential packaging defect.

Pradaxa
Pradaxa Facts
  1. Uses Treat and prevent blood clots; reduce the risk of stroke
  2. Side Effects Excessive bleeding; acute kidney or liver failure
  3. Manufacturer Boehringer Ingelheim
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Pradaxa (dabigatran) is an anticoagulant. People know it better as a blood thinner.

Boehringer Ingelheim makes Pradaxa. The U.S. Food and Drug Administration first approved Pradaxa in 2010.

Pradaxa can treat and prevent blood clots. This can reduce the risk of stroke.

What Is Pradaxa Used For?

Blood Clot on X-Ray
Pradaxa reduces the risk of stroke by lowering the chance of a blood clot forming.

Pradaxa is used in patients with atrial fibrillation (irregular heartbeat) not caused by a heart valve problem. It lowers the risk of stroke in these patients. It does this by cutting the risk that a blood clot will form in the heart and go to the brain.

The FDA also approved Pradaxa to treat deep vein thrombosis (DTV) and pulmonary embolism (PE) in patients who have been treated with injectable blood thinner for five to 10 days.

DTV is a serious condition that occurs when a blood clot forms in the deep veins in the body. This is usually in the legs and thighs. PE occurs when a blood clot becomes lodged in a blood vessel in the lung.

Doctors also prescribe Pradaxa to prevent DVT and PE in patients who have had hip replacement surgery.

How Does Pradaxa Work?

Pradaxa is known as a direct thrombin inhibitor. It blocks the blood’s central clotting agent, thrombin. This lowers the chance of blood clots forming.

Pradaxa Dosage

Pradaxa comes in 75 mg, 110 mg and 150 mg capsules. Most people take 150 mg capsules twice a day.

People with kidney problems may take lower doses of Pradaxa because the drug is eliminated through the kidneys. The FDA advises doctors to check a patient’s kidney function before prescribing Pradaxa and to reassess kidney function throughout treatment with the drug.

How to Take Pradaxa

A patient’s doctor will explain the best way to take Pradaxa. But the drug’s manufacturer instructs patients to swallow Pradaxa whole with a full glass of water.

It advises patients not to break, chew or empty the capsules. Patients can take Pradaxa with or without food.

Pradaxa Overdose

It is possible to overdose on Pradaxa. Overdosing on Pradaxa increases a patient’s risk of bleeding.

If a person suspects a Pradaxa overdose, he or she should immediately contact a poison control center or seek emergency treatment.

Pradaxa Recall

Pradaxa 75 mg box packaging
Boehringer Ingelheim recalled Pradaxa 75 mg tablets because of a potential packaging defect.

In November 2012, Boehringer Ingelheim announced a nationwide voluntary recall of a single manufacturing lot of Pradaxa 75 mg capsules. The company cited a potential packaging defect.

It warned that a damaged bottle could allow moisture to get into the bottle. This could harm the quality of the drug.

Pradaxa Side Effects

The most serious Pradaxa side effect is uncontrolled bleeding. For five years after the FDA approved Pradaxa, there was no way to reverse these bleeding events, and people sometimes died. There is now an antidote for Pradaxa bleeding.

Some people have filed Pradaxa lawsuits against Boehringer Ingelheim over bleeding injuries and deaths.

Researchers also have reported incidents of acute kidney failure, stroke and suspected liver failure with Pradaxa use. Other side effects of Pradaxa include gastrointestinal issues like indigestion, upset stomach, burning and stomach pain.

Pradaxa Warnings and Precautions

According to the drug’s prescribing information, you should not take Pradaxa if you have a mechanical prosthetic heart valve.

Fact
People with prosthetic heart valves should not take Pradaxa.

Pradaxa is also not appropriate for patients with active pathological bleeding or a history of hypersensitivity reaction to Pradaxa.

The FDA requires a black box warning — the agency’s strongest warning — to alert the public of the risk of spinal and epidural hematomas in patients treated with Pradaxa who are receiving neuraxial anesthesia or undergoing spinal puncture.

Pradaxa patients who have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent paralysis.

Stopping Pradaxa

Patients should not stop taking Pradaxa without first talking with their doctor. The FDA warns that missing doses may increase the risk of blood clots or stroke. Suddenly stopping Pradaxa also increases the risk of thrombotic events such as strokes.

Pradaxa, Xarelto and Warfarin

People may compare Pradaxa to other blood thinners like Xarelto and Warfarin. The FDA approved the drugs at different times. Different manufacturers make them.

Pradaxa vs. Xarelto vs. Warfarin
CATEGORY PRADAXA XARELTO WARFARIN
Manufacturer Boehringer Ingelheim Bayer and Janssen Pharmaceuticals (Johnson & Johnson) Bristol-Myers Squibb
FDA Approval Date 2010 2011 1954
Cost Almost $6,000 a year Almost $6,000 a year $200 a year
Uses Atrial fibrillation not caused by heart valve problem; lowering chances of blood clot forming in heart; deep vein thrombosis; pulmonary embolism Same as Pradaxa Same as Xarelto and Pradaxa; plus to reduce the risk of death from heart attacks and other thromboembolic events after a heart attack
Bleeding Antidote Praxbind (2015) AndrexXa (2018) Vitamin K
Routine Blood Tests Required No No Yes

Pradaxa Interactions

Patients should let their doctor know about any medications or supplements they take prior to starting Pradaxa. Taking Pradaxa at the same time as certain other medications can lead to drug interactions. Pradaxa drug interactions can make the medications less effective. They can also be dangerous.

Pradaxa may interact with substances, including:
  • Dronedarone
  • Ketoconazole
  • Rifampin
  • Antacids
  • St. John’s wort
  • Mifepristone
  • Cyclosporine
  • Cobicistat
  • Aspirin and aspirin-like drug
  • Nonsteroidal anti-inflammatory drugs such as ibuprofen naproxen and celecoxib

Please seek the advice of a medical professional before making health care decisions.

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15 Cited Research Articles

  1. Brown, M. and Jeffress, M. (n.d.). Are Pradaxa and Xarelto as good as Coumadin (Warfarin) for Atrial Fibrillation and to Prevent Stroke? Retrieved from http://www.center4research.org/atrial-fibrillation-pradaxa-xarelto-better-worse-coumadin-warfarin/
  2. U.S. Food and Drug Administration. (2015). Pradaxa prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf
  3. Everyday Health. (n.d.). What is Pradaxa (Dabigatran)? Retrieved from https://www.everydayhealth.com/drugs/pradaxa
  4. Kaiser Permanente. (n.d.). Pradaxa 150 mg capsule. Retrieved from https://healthy.kaiserpermanente.org/health/care/consumer/health-wellness/drugs-and-natural-medicines/drug-encyclopedia/medicine-information/!ut/p/a1/fc5BT4MwFMDxz7IDR-mDAuu8dSxiQdjMiGIvhs2uI2GUdN3Ivr2AeDBR360vv_7zEEcF4k15rWRpKtWU9fDmwXsObL1cOhTAYT6wTUyyFSEuhBi9ohhxWavdiN-OxrT3FljwoS9SNPvbXau0qYWxAPFhx1ao8APXI3jgtNlhIhHX4iC00PZF95WhcR4jXdfZUilZC3uvTn3ily9HdTao-Cn7q_j_h8MEHuLtF1h7CwIsDR9DliUA0XwCGwqMpOA7QHEALMhxMk8zByJvAoDZ81iINgH0NsmTl0WCAdxv8MdQQO2J3HB9fTpsWcXobPYJQd5ztA!!/dl5/d5/L2dBISEvZ0FBIS9nQSEh/
  5. Pradaxa. (n.d.) Important Safety Information and Use of Pradaxa. Retrieved from https://www.pradaxa.com/
  6. Cision PR Newswire. (2018, April 17). FDA Provides Full Approval to Praxbine, Specific Reversal Agent for Pradaxa. Retrieved From https://www.prnewswire.com/news-releases/fda-provides-full-approval-to-praxbind-specific-reversal-agent-for-pradaxa-300631175.html
  7. Institute for Safe Medication Practices. (2015, September 23). QuarterWatch Annual Report Issue. Retrieved from  https://www.ismp.org/QuarterWatch/pdfs/2014Q4.pdf
  8. Schroeder, M. (2016, October 13). What You Should Know Before Taking New Blood Thinners. Retrieved from  http://health.usnews.com/health-news/patient-advice/articles/2016-10-13/what-you-should-know-before-taking-new-blood-thinners
  9. Thomas, K. (2012, November 2). A promising drug with a flaw. The New York Times. Retrieved from  http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html?_r=0
  10. Hart, R.G. et al. (2012). Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke, 43(6): 1511–1517. Retrieved from  http://www.ncbi.nlm.nih.gov/pubmed/22492518
  11. Food and Drug Administration. (2012). Medication guide: Pradaxa. Retrieved from  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf
  12. Bankhead, C. (2012, February 29). Bleeding risk with blood thinner cited. MedPage Today. Retrieved from  http://www.medpagetoday.com/Cardiology/Arrhythmias/31427
  13. Harper, P., Young, L. & Merriman, E. (2012). Bleeding risk with dabigatran in the frail elderly. New England Journal of Medicine, 366: 864–866. Retrieved from  http://www.nejm.org/doi/full/10.1056/NEJMc1112874
  14. Silverman, E. (2012, November 6). Was the FDA safety analysis for a popular bloodthinner flawed? Forbes. Retrieved from  http://www.forbes.com/sites/edsilverman/2012/11/06/was-the-fda-safety-analysis-for-a-popular-bloodthinner-flawed/
  15. SurgicalCare.net. (n.d.). Warfarin Reversal Guideline. Retrieved from http://www.surgicalcriticalcare.net/Guidelines/Warfarin%20Reversal%20Guideline%202012.pdf
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