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There has never been a more important time for Pradaxa users to vigilantly report complications from the drug. Specifically, users of the drug need to let physicians know of any symptoms of gastrointestinal bleeding, such as abdominal pain and changes in the color of your stool.

While not going so far as to recommend patients stop using Pradaxa, the FDA has announced that it is now evaluating reports of serious bleeding events in patients taking Pradaxa.

As we noted in an earlier blog, last month Boehringer Ingelheim acknowledged 260 deaths as a result of bleeding. The Eurpoean Medicines Agency (EMA) recommended updated product information stating that renal function should be assessed in any patient before starting Pradaxa treatment. Furthermore, renal function should continue to be assessed at least once a year for any patient over 75 years of age.

Once predicted to become one of the leading therapies in the atrial fibrillation drug market, it now appears that Pradaxa will not live up to its marketing hype as both the EMA and the FDA are currently reviewing the overall safety profile of Pradaxa.

The FDA warns that patients currently taking Pradaxa should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase the risk of stroke. However, if you are experiencing any of the following signs or symptoms of bleeding, seek immediate care:

  • 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

The FDA would like anyone experiencing adverse events involving Pradaxa to contact the FDA MedWatch program. The easiest way to do this is to fill out the MedWatch Online Voluntary Reporting Form. Hit the button marked "Begin" on the right side to report any adverse events and be as specific as possible.

The MedWatch form is confidential and absolutely necessary for the FDA in order to make an informed decision about the saftey of Pradaxa.

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