Elderly Females at Risk of Severe Pradaxa Side Effects

May 8, 2012 — A new study has analyzed the risk of severe side effects among patients who switched from Coumadin (warfarin) to Pradaxa (dabigatran). Dr. Mark Wurster presented the research at the Thrombosis & Hemostasis Summit of North America 2012. The study found that elderly women had the highest risk of suffering severe Pradaxa side effects, which included cases of fatal gastrointestinal bleeding.

The researchers analyzed data on 113 patients. They compared the rate of side effects during six months while the patients were on warfarin, versus six months after the patients had switched to Pradaxa. The vast majority of the patients used 150-mg doses of Pradaxa, except two, who used 75-mg doses.

Of these patients, just one stopped taking warfarin due to a serious side effect. In comparison, 13 patients who were taking Pradaxa were forced to stop taking the medication due to a severe side effect. One Pradaxa patient died from a severe gastrointestinal bleeding event. Other severe Pradaxa side effects included rectal bleeding, gastrointestinal bleeding, bleeding in the brain due to head trauma, blood clots (deep vein thrombosis), blood clots in the heart, and transient blood clots in the brain (transient ischemic attack).

Elderly women were most likely to suffer a severe side effect. Just 29% of all patients in the study were female, but females comprised 71% of the people who suffered severe side effects.

The new research highlights the risk of prescribing Pradaxa to older people, and especially those who have kidney problems. Pradaxa can easily build up to dangerously high levels in patients whose kidneys do not efficiently clean it out of the bloodstream. Older people with kidney problems have the highest risk of severe Pradaxa bleeding events.

The doctors also highlighted the risk of missing a dose of Pradaxa. The medication has a very short half-life, so missing one or two doses effectively eliminates protection from deadly blood clots. The researchers noted that one patient developed major blood clots after missing just two doses of Pradaxa. Because at least 40% of elderly people miss a dose at least once per week, this is a serious risk of using Pradaxa. Warfarin, in comparison, has a relatively long half-life, and missing a few doses is usually not a serious problem.

Another problem with Pradaxa is that it has no quick reversal agent — only 2-3 hours of dialysis can remove Pradaxa from the body. In patients who have poor kidney function, high levels of Pradaxa can trigger a major internal bleeding event. Even when the person goes to the hospital, however, doctors may have no way of stopping uncontrollable bleeding. This is because Pradaxa has no effective reversal agent.

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