Recent news on Pradaxa (dabigitran) has focused on this drug being associated with at least 2000 lawsuits due to serious bleeding, including at least 120 reported deaths. You may recall, when the drug was being launched a couple of years ago, the claim of a primary advantage to using Pradaxa was that no monitoring would be needed. This, no doubt, would be a selling point for the older adult who is tired of traveling to the physicians office to get a lab test when taking the drug Coumadin (warfarin), the “gold standard” in anti-coagulation therapies for many years. But if Pradaxa is a drug that is as effective as warfarin, and can still lead to serious bleeding events, why wouldn’t monitoring be performed to at least guard against harm? Almost 60% of adverse drug events are due to lack of monitoring, and any drug that has the potential to cause serious bleeding should be no exception. The claim that “no monitoring is needed” goes against the basic principle of drug safety in trying to prevent harm from medications. This would be especially true in those over 75 years old, as some European data suggest older adults are at higher risk for harms from Pradaxa. So perhaps the drug should not be used in older adults, especially since there is no antidote for bleeding from the drug, and since many older adults will not be properly counseled on drugs to NOT take with Pradaxa, such as aspirin or NSAIDs like Motrin and Aleve. Other drugs that increased the risk for bleeding in the RE-LY trial were antidepressants, specifically SSRIs and SNRIs, drugs like sertraline, fluoxetine, citalopram, venlafaxine and others.
In defense of Pradaxa, other large observational studies have not proven that Pradaxa is associated with a higher risk of bleeding in older adults. But time will tell since data may not be revealing until well after the drug has been on the market. The recent focus on adverse events from Pradaxa may also be heightened by litigation attorneys and the fact that the manufacturer did have internal communications suggesting that monitoring may be beneficial in a subset of patients. This may skew the reality of the actual bleeding risk with use of the drug.
In balance and out of fairness, if Pradaxa is a drug that is thought to benefit an older adult, it should be used in those with a drug regimen that is free from interacting drugs that can increase the risk of bleeding, and the benefits clearly outweigh the risks. Dosing the drug properly in those with renal impairment is also critical to safety. Patient education is also paramount by teaching to look for any signs of bleeding, whether it be bleeding from the gums or nosebleeds, or any bruising or bleeding from other sites. Patients also need to stay away from OTC pain relievers since chronic pain is a common geriatric syndrome in which older adults frequently try anything they perceive to be safe, and the perception is that if a drug is available without a prescription that the drug is safe.