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Home / Uncategorized / Pradaxa Ranked as Most Reported Dangerous Drug...

Pradaxa Ranked as Most Reported Dangerous Drug in 2011

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The Institute for Safe Medication Practices publishes the trademarked report QuarterWatch. ISMP analyzed direct reports of the U.S. Food and Drug Administration’s Adverse Event Reporting System (AERS) for 2011. The most frequently identified suspect drugs in AERS were anticoagulants. The two most common anticoagulants reported were Dabigatran (PRADAXA) and Warfarin (COUMADIN). The report noted, “While a therapeutic goal of preventing strokes, pulmonary embolism, and other harm through unwanted blood clots is a worthy objective, these results demonstrate that treatment is accompanied by substantial risks.”

QuarterWatch is an independent publication that monitors all domestic, serious adverse drugs and is designed to keep track of any serious or fatal adverse drug events that the FDA receives.  Pradaxa was approved in 2010 for the prevention of stroke in patients with atrial fibrillation. Pradaxa accounted for so many reports of serious adverse drug events that it showed up in multiple categories.

Pradaxa was cited as follows:

  • Overall number of reports: 3,781
  • Number of deaths: 542
  • Hemorrhage cases: 2,367
  • Cases of acute renal failure: 291
  • Cases of stroke: 644
  • Liver failure: 15

Other leading prescription drugs with serious events cited were : Coumadin (Warfarin) with 490, Levaquin (Levofloxacin) with 393, Carboplatin with 376, and Zestril (Lisinopril) with 351 reports.

The FDA at this time does make it clear there is a beneficial goal of anticoagulants in preventing strokes, pulmonary embolism, and unwanted blood clots. Patients should not stop taking Pradaxa without the advice from their doctor or health professional. If you currently take Pradaxa be aware of these symptoms:

  • unusual bleeding from the gums
  • nose bleeding that happens often
  • menstrual or vaginal bleeding that is heavier than normal
  • bleeding that is severe or you cannot control
  • pink or brown urine
  • red or black stools (looks like tar)
  • bruises that happen without a known cause or that get larger
  • coughing up blood or blood clots
  • vomiting blood or vomit that looks like coffee grounds

If you experience any of these symptoms, please seek medical attention immediately. If you believe you have been injured by a drug, please call Longo Legal, PLLC toll free at (855) 566-4648 to find out your rights.

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