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Pradaxa May Cause Bleeding, Including Gastrointestinal, Cerebral Hemorrhaging, Kidney Injury, Stomach Ulcers, Heart Attacks, Strokes, Thrombotic Thrombocytopenic Purpora (TTP) and death.

Pradaxa, a popular drug used to prevent blood clots in people at risk for a heart attack, has been linked to some serious side effects, especially bleeding. In addition to gastrointestinal and cerebral hemorrhaging, Pradaxa bleeding can include eye (conjunctival, ocular, retinal) bleeding, musculoskeletal bleeding, fatal intracranial bleeding, respiratory tract bleeding, and skin bleeding, according to its label. As a matter of fact, bleeding, including life-threatening and fatal bleeding, is the most commonly reported Pradaxa side effect.

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Other Pradaxa side effects include Thrombotic Thrombocytopenic Purpura or TTP. TTP is a rare blood condition that causes blood clots to form in small blood vessels throughout the body. The blood clots can cause serious problems if they block the blood vessels and limit blood flow to the brain, kidneys, or heart.

For years, it was thought the commonly prescribed Pradaxa-aspirin combination would cause less bleeding than an alternative blood thinner, Warfarin. But recently, a study conducted by the U.S. Centers for Disease Control (CDC) and published in the Archives of Internal Medicine found the risk of hemorrhaging among Pradaxa-aspirin patients was significantly higher than thought. While the CDC study did find that Warfarin was associated with a higher rate of bleeding than the Pradaxa-aspirin combo, the combination therapy did not do as well in that area as was expected. For both regimens, the number of hospital admissions because of bleeding was similar. And bleeding-related visits to emergency department visits were only 50 percent lower for those on the Pradaxa-aspirin combo.

A common type of Pradaxa bleeding is gastrointestinal bleeding. A recent study in the New England Journal of Medicine found that patients taking Pradaxa are 12 times more likely to suffer recurrent ulcers and Pradaxa gastrointestinal bleeding than those who received a combination of aspirin and a heartburn pill.

Proton Pump Inhibitors (PPIs), such as Prilosec Nexium, Prevacid, Aciphex, and Protonix, are often prescribed to reduce the risk of gastric bleeding from the Pradaxa-aspirin combo. But it now appears that those drugs might not be appropriate for Pradaxa users. That’s because Pradaxa does not have anti-clotting effects until it is converted or metabolized into its active form with the help of a liver enzyme called CYP2C19. But it is known that at least Prilosec blocks the CYP2C19 liver enzyme, thereby reducing the effectiveness of Pradaxa. It is not know how other PPIs interact with Pradaxa, but the U.S. Food & Drug Administration has warned that Pradaxa should not be used with many PPIs.

The “Warnings and Precautions” section of the Pradaxa label cautions that patients should discontinue Pradaxa five days prior to elective surgery. In regards to transient ischemic attack or stroke, that section also warns that the much-used combination use Pradaxa and aspirin in these patients was not shown to be more effective than Pradaxa alone, but was shown to increase major bleeding. Pradaxa is also contraindicated in patients with active pathological bleeding, including peptic ulcer or intracranial hemorrhage.

The Pradaxa label advises doctors to counsel their patients that Pradaxa will cause them to bruise and bleed more easily, and that it will take longer than usual to stop bleeding. Patients should report any unanticipated, prolonged, or excessive bleeding, or blood in their stool or urine.