Pradaxa's bleeding concerns
  • Mon, 06/18/2012 - 3:26pm

Despite its stamp of approval from the FDA, some doctors are hesitant to prescribe a new blood thinner, dabigatran etexilate (Pradaxa), because it has no known reversal agent that can stop bleeding.
According to WebMD, the FDA approved Pradaxa to be taken twice daily in order to prevent strokes in patients with arterial fibrillation, a type of irregular heartbeat that increases one’s chance of blood clots. As MedicineNet states, blood clots can cause strokes that cause serious brain injury due to a lack of oxygen and glucose to the brain’s cells when an artery is obstructed.
Boehringer Ingelheim developed Pradaxa, which was proven to be more effective than leading blood thinner warfarin in decreasing the occurrences of ischemic and hemorrhagic strokes in an 18,000-patient trial. Patients older than 75 tended to suffer a higher risk of major bleeds on Pradaxa, but the risks associated with major bleeds were similar in patients taking both Pradaxa and warfarin.
“What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding” said Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.
Pradaxa was meant to replace warfarin, which hit the market in the 1950s. Patients taking warfarin must have periodic blood tests and limit their diet and lifestyle.
“The good news is you now have an alternative to warfarin,” said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration facility in Loma Linda, California, “but you can kill a patient just as easily with the new drug as you could the old drug.”
If warfarin causes serious bleeding, a doctor can administer vitamin K to counteract the drug. A reversal agent for Pradaxa has yet to be developed.
Bleeding is a common risk when taking blood thinners, and can result from improper use like taking too little or too much, or taking other drugs that can cause bleeding. If you are taking Pradaxa or warfarin and have questions or concerns, be sure to contact your physician.


About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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