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Side Effects of Pradaxa

Even though Pradaxa has been found to be mildly effective at treating certain types of strokes, there are a number of potentially life-threatening side effects associated with the drug. Notify your healthcare provider immediately if you develop any signs of bleeding, such as:

  • Unusual bleeding
  • Blood in the urine or stools
  • Vomiting blood

Some of the more common mild side effects of Pradaxa may include:

  • Indigestion
  • Heartburn
  • Abdominal (stomach) pain
  • Gastroesophageal reflux disease (GERD)
  • Ulcers of the digestive tract
Prior to Taking Pradaxa

To ensure that you can take Pradaxa safely, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • a history of stomach ulcer or bleeding; or
  • if you are older than 75.

The FDA has classified Pradaxa as a Pregnancy Category C medication, which means that it is not currently known if the drug will harm an unborn baby. You should consult your healthcare professional immediately if you are pregnant or planning on becoming pregnant while being treated with Pradaxa. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What is at Issue?

Boehringer Ingelheim has stated that the vast majority of the fatalities involving Pradaxa were caused by bleeding complications. The updated list of fatalities was released after an inquiry by Japanese officials, whose country has reported at least 14 deaths associated with Pradaxa use. In response to this alarming trend, Japan has called on Boehringer to add strengthened warnings to labels of Pradaxa.

Taking the abnormally high number of fatalities into consideration, a number of researchers have called into question the validity of Pradaxa’s pre-approval clinical trials, stating that the drug should never have been approved because the trials were inherently flawed.

The drug was manufactured to be a replacement for warfarin, and is supposed to require less monitoring and be easier to use. However, Warfarin can be quickly counteracted by doses of Vitamin K when an internal bleeding problem occurs. This does not work with Pradaxa or any of the other newer generation of blood thinners.

This new class of medications – which includes Xarelto (Bayer and Johnson & Johnson), Eliquis (Bristol-Myers Squibb and Pfizer), and Lixiana (Daiichi Sankyo) – are designed to prevent strokes in patients suffering from atrial fibrillation, a form of irregular heartbeat common among the elderly. All of these drugs are competing for a market estimated to be worth between $10 and $20 billion annually.

Like other blood-clotting agents, Pradaxa’s ability to treat massive strokes comes at the risk of internal bleeding, which can also be fatal. It has been theorized that Pradaxa may have too much of an effect on the blood clotting process, which leads to hemorrhages. There have also been conflicting reports indicating that the drug does not have enough of an effect on clotting, resulting in pulmonary embolisms and deep vein thrombosis (DVT).

In recent studies, Pradaxa bleeding side effects included:

  • Any bleeding – in up to 16.6 percent of people taking Pradaxa (compared to 18.4 percent with warfarin)
  • Major (serious) bleeding – up to 3.3 percent (compared to 3.6 percent with warfarin)
  • Life-threatening bleeding – up to 1.5 percent (compared to 1.9 percent with warfarin)
  • Bleeding in the brain – up to 0.3 percent (compared to 0.8 percent with warfarin)

In Europe, doctors have been advised to test patients’ kidney functions to reduce chances of bleeding complications prior to initiating a regimen of Pradaxa. The drug was approved for use in the United Kingdom on November 1, 2011. Here at home in the United States, Pradaxa was only approved for use in October 2010, but has since received more customer complaints to the U.S. Food & Drug Administration (FDA) than approximately 99% of the other drugs on the market.

According to research conducted by the Institute of Safe Medication Practices (ISMP), the FDA received hundreds of reports of Pradaxa side effects within weeks of the drug being released into the market. The vast majority of these side effects involved severe internal bleeding problems in elderly patients. In total, the administration received over 300 complaints about Pradaxa in the last quarter of 2010 alone, compared to just 202 complaints involving warfarin.

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