Stomach problems and gastrointestinal bleeding. According to Dr. Stephen Kimmel of the Un. For example, in treating trauma patients, ER doctors can use the elapsed time from the last dose to estimate the clotting effect. With warfarin Coumadin , on the other hand, we can measure how effective it is by its level in the blood stream measured in INR International Normalized Ratio. With an INR below 2. With an INR of 4. Pradaxa, for example, is a direct thrombin inhibitor , whereas warfarin affects nearly every stage in the anticoagulation process.
Thrombin is an enzyme that converts soluble fibrinogen into insoluble fibrin. Fibrin is a fibrous protein involved in the clotting of blood. It forms a mesh or clot over a wound. The lack of a readily available method to determine the degree or current level of anticoagulation is a major challenge for ER physicians and staff treating trauma patients. If you have an accident involving bleeding, EMTs can call ahead to the ER and get the staff ready to help you.
To print your own I. Wallet Card. Pradaxa: Too Effective? Pradaxa, in particular seems to work almost too well. Pradaxa won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and thus captured a significant market share. In some patients there is excessive bleeding that is catastrophic usually in older or weaker patients. Pradaxa has been associated with deaths in the ER before doctors had Praxbind, the Pradaxa reversal agent, to stop people from bleeding to death.
Warfarin on the other hand has several proven, time-tested reversal or antidote strategies. Pradaxa dabigatran won the FDA sweepstakes by being the first new anticoagulant to get FDA approval and consequently captured a significant share of the anticoagulant market.
Pradaxa comes in two doses in the United States, mg twice daily or 75 mg twice daily. In the RELY trial, Pradaxa was not only equal to warfarin, but it proved to be superior to it in preventing stroke. Bleeding rates in the head were lower than with Warfarin. However, bleeding from the stomach or bowels was higher. The most common side effect was stomach pain.
Xarelto rivaroxaban was the second drug available in the United States. Xarelto comes in two doses, 20 mg daily or 15 mg daily. In contrast to Pradaxa, it is a small pill taken once-a-day. In the Rocket AF trial, Xarelto also significantly lowered the risk of bleeding in the brain and head compared to warfarin.
Eliquis apixaban was third to be approved, comes in two doses, 5 mg twice daily or 2. Similar to Xarelto, the risk of bleeding in the brain and head was lower versus warfarin. However, this drug was unique in that bleeding from other sites including the stomach, bowels, and bladder was less. In the Aristotle trial, Eliquis was at least as good and tended to be better than warfarin at preventing stroke. Eliquis is the only drug that can claim that survival improved with its use compared to warfarin.
The reported bleeding events tend to occur mainly in elderly patients median age of 80 which raises a question regarding safe dosing and monitoring in older patients. Elderly patients often have mild to moderate renal impairment, which can cause plasma levels of the NOAC to increase up to three times those with normal renal function. The FDA rejected the lower mg twice-daily dose of Pradaxa dabigatran tested in the RE-LY trial, instead approving a mg twice-daily dose just for patients with severe renal impairment.
In comparison, warfarin had a score of Pradaxa dabigatran had a score of If you have atrial fibrillation not caused by a heart valve problem and are currently taking warfarin, you may have options. Spinal or epidural blood clots hematoma. People who take PRADAXA and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move paralysis.
Your risk of developing a spinal or epidural blood clot is higher if:. If you take PRADAXA and receive spinal anesthesia or have a spinal puncture, your healthcare provider should watch you closely for symptoms of spinal or epidural blood clots. Tell your healthcare provider right away if you have back pain, tingling, numbness, muscle weakness especially in your legs and feet , loss of control of the bowels or bladder incontinence.
Tell your healthcare provider about all your medical conditions, including if you have kidney problems, bleeding problems, stomach ulcers, or have antiphospholipid syndrome APS. Tell your healthcare provider if you are pregnant or plan to become pregnant. This drug got the green light after a head-to-head trial with warfarin generic, Coumadin in people with an irregular heart beat from atrial fibrillation.
Pradaxa was at least as effective as warfarin for preventing stroke-causing blood clots, and possibly caused fewer bleeding side effects. In addition, it is easier to use. Since then, studies of Pradaxa have slightly dampened the enthusiasm for the new drug. Take, for example, the results of a University of Pittsburgh survey of 9, men and women covered by Medicare.
All had atrial fibrillation, an irregular heart rhythm that lets blood clots form in the heart. None had damaged heart valves. When these clots get into the bloodstream, they can cause strokes. In this group, 1, had been prescribed Pradaxa and 8, took warfarin. The researchers followed these men and women until they either stopped using the drug, switched to a different blood thinner, died, or until December The bleeding sites tended to differ.
Bleeding in the stomach and intestines was slightly higher among Pradaxa users. Bleeding in the head was slightly higher among warfarin users. Black patients and those with chronic kidney disease were more likely to bleed from Pradaxa. For decades, the best way to prevent stroke from atrial fibrillation was by taking warfarin Coumadin. You also need to pay attention to what you eat, because a sudden meal with a lot of vitamin K can counteract warfarin.
Then came Pradaxa. After doctors had been prescribing it for a while, they noticed that it was causing more episodes of major bleeding than had been expected. The FDA ordered that additional studies be performed on the safety of Pradaxa in the real world.
Some studies, like the one from, the University of Pittsburgh, showed a higher bleeding risk with Pradaxa than with warfarin. Other studies show the opposite. Since , two other blood thinners have been approved to prevent strokes in people with atrial fibrillation and no heart valve problems: apixaban Eliquis and rivaroxaban Xarelto.
Post-approval studies on the safety of these drugs are still ongoing. One downside of the three new drugs: they are much more expensive than warfarin. One upside: none require regular blood tests to adjust the dose. One big unknown: the long-term side effects. How do you and your doctor decide which drug is right for you if you have atrial fibrillation?
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