FDA Issues Warning About Pradaxa©

The Food and Drug Administration released a drug safety communication in December, 2011 cautioning against potentially deadly effects linked to Pradaxa©.  The FDA warned that Pradaxa© has been linked to excessive blood loss in the brain, kidneys and gastrointestinal region.  If you or a loved one has taken Pradaxa© then please read this important information.

Pradaxa© is an anti-coagulant (or blood thinner) which is taken orally to combat the risk of stroke or blood clots.  It is made by the Boehringer Ingelheim pharmaceutical company.

Critics of the drug say that it was rushed to market without properly testing for all negative side effects.

The FDA warns that anyone taking Pradaxa© should be aware that they will bruise more easily, and it may take longer for bleeding to stop.  If you’re currently taking Pradaxa©, call your healthcare professional immediately if you have experienced these signs of bleeding:

  • Unusual bleeding from the gums
  • Frequent nosebleeds
  • Heavier than usual menstruation
  • Uncontrollable or severe bleeding
  • Urine that is pink or brown
  • Blood in the stool
  • Unexplained bruises, or bruises that become larger
  • Coughing up blood or blood clots
  • Vomiting blood or vomit that looks like coffee grounds.

The FDA cautions Pradaxa© users against ceasing its use without talking to your doctor.  Suddenly stopping the use of an anti-coagulant can lead to an increase in the possibility of a stroke.

If you or a family member have suffered a serious injury while taking Pradaxa©, you can call our office for a free consultation.

For more information read the FDA’s Safety Communication.

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