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Elderly Females at Risk of Severe Pradaxa Bleeding

Elderly Females at Risk of Severe Pradaxa Bleeding

May 8, 2012 — Research that was presented at the Thrombosis & Hemostasis Summit of North America 2012 by Dr. Mark Wurster highlights the risk of severe, life-threatening Pradaxa side effects among patients who switched from Coumadin (warfarin) to Pradaxa (dabigatran). The study found that older females have a significantly higher risk of severe bleeding and other side effects of Pradaxa.

The study involved 113 patients who were recently switched from warfarin to Pradaxa. The researchers analyzed the side effects in the six months before the patients switched to Pradaxa (while they were taking warfarin), and in the first six months on Pradaxa. Most of these patients were taking 150-mg doses of Pradaxa, but two used 75-mg doses.

During the warfarin treatment period, only one patient had a serious side effect and needed to stop taking the drug. In comparison, there were 13 serious events in the Pradaxa treatment period. One patient died from a severe gastrointestinal bleeding event. Other patients suffered non-fatal gastrointestinal bleeding, rectal bleeding, brain hemorrhage from minor head trauma, deep vein thrombosis (DVT), blood clots in the heart, and transient blood clot in the brain.

The researchers found that elderly females were most likely to suffer severe Pradaxa bleeding. The average age of people who had severe side effects was 73.4 years. Although women comprised only 29% of the total Pradaxa-users, women made up 71% of the people who suffered complications.

The high risk of side effects highlights the risk of prescribing Pradaxa to older people, particularly those with impaired kidney function. If the kidneys do not effectively clear Pradaxa from the bloodstream, the medication can quickly build up to dangerously high levels. This significantly increases the risk of bleeding. Once the patient begins bleeding, it may be difficult or impossible for a physician to stop the bleeding, because Pradaxa has no effective reversal agent. Dialysis is the only way to remove Pradaxa from the bloodstream.

Researchers noted another problem with Pradaxa is that it has a short half-life. This means that if a patient misses a dose or two, they have no protection against blood clots. The doctors in the presentation said that they have seen patients develop blood clots within two days of missing a dose of Pradaxa. At least 40% of patients miss a dose of medication at least once a week. Warfarin, on the other hand, has a relatively long half-life, so when patients miss a dose or two, they are still protected from potentially fatal blood clots.

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