A recent Pradaxa study has highlighted the risk of gastrointestinal bleeding among Pradaxa patients.

A recent study published in the peer-reviewed journal Circulation compared Pradaxa to an older anticoagulant called Warfarin. The study did find that Pradaxa did a somewhat better job of reducing the risk of strokes and some other clot-related problems compared to Pradaxa.

However, researchers also found that patients taking Pradaxa had a significantly higher rate of gastrointestinal bleeding compared to patients taking Warfarin. Critically, the study found the risk of gastrointestinal bleeding was dose-dependent, which means that patients who took more Pradaxa had a higher risk of gastrointestinal bleeding.

In an observational study like this, dose-dependence is viewed as evidence that the link between a drug and a risk is not coincidental.

Several factors could potentially explain the difference between the risk of gastrointestinal bleeding complications in Pradaxa and Warfarin. Pradaxa is marketed as easier to take than Warfarin, requiring only one pill a day and none of the frequent blood tests in Warfarin patients.

However, studies have suggested that these blood tests, which are used to see how strongly Warfarin is affecting the patient, could also benefit Pradaxa users, as many have too much or too little of the drug in their blood, paradoxically risking stroke and uncontrollable bleeding.

Additionally, Pradaxa does not have a known reversal agent. Warfarin works by interfering with vitamin K, which the body uses in the clotting process. This means that if a patient on Warfarin experiences an uncontrollable bleeding event like gastrointestinal bleeding, doctors can give them a very high dose of vitamin K (called a “megadose”), which effectively turns off the drug so they can stop bleeding.

Newer-generation drugs like Pradaxa have no known reversal agent, making it much harder for physicians to treat gastrointestinal bleeding when it does occur.

Pradaxa is a type of drug called a blood thinner or an anticoagulant. This type of drug is designed to make it harder for people to form blood clots. While blood clots are a normal part of the healing process, there are some situations in which medical professionals would want to short-circuit this process.

In stroke, pulmonary embolism, some types of heart attack, and related health problems, blood clots form too easily, and may block the supply of blood to critical tissues. Drugs like Pradaxa make it harder to form blood clots, and reduce the risk of these complications. But blood thinners in general, and Pradaxa in particular, may carry the risk of serious side effects.

All blood thinners carry the risk of working too well. Without the ability to form blood clots, a person can bleed to death. This can include causes such as internal injuries like brain hemorrhages, pulmonary bleeding, and gastrointestinal bleeding. If a blood thinner like Pradaxa works too well, a patient could be at an increased risk of gastrointestinal bleeding and other complications.

Lawsuits have been filed alleging that the makers of Pradaxa have aggressively marketed their drug in spite of the risk of gastrointestinal bleeding, and the availability of safer alternatives.