The dangerous side effects of the popular blood-thinner Pradaxa have been well-documented.
- Serious risks of developing life-threatening bleeding problems have been identified by researchers.
- Over a thousand deaths have been attributed to Pradaxa bleeding problems.
- Pradaxa has been identified as the most complained-about drug to the Food and Drug Administration.
- And there are several thousand state and federal Pradaxa bleeding lawsuits pending in which victims of this dangerous side effect are seeking damages and others are seeking compensation for the loss of a loved one.
Therefore it was surprising to see the following posting on the web site of the non-profit Institute for Safe Medical Practices involving ways of making Pradaxa safer:
“Two new studies of the anticoagulant dabigatran (PRADAXA) show that the high risk of hemorrhage in older patients can be substantially reduced with two options currently available to healthcare providers in Canada and Europe, but not in the US: 1) a lower dose option (110 mg BID), and 2) a new laboratory monitoring test capable of identifying patients at highest risk for serious bleeding. While the US Food and Drug Administration (FDA) previously disallowed a lower dose and the new laboratory test monitoring in the US, the stakes are high—a dabigatran clinical trial showed that 16% of patients experienced a bleed in 1 year, including 3.3% with bleeds that required emergency medical treatment.”
The Institute editorialized: “FDA should strongly consider this important additional information about dabigatran, reassess the one-dose-fits-all recommendation, and reevaluate the Hemoclot Thrombin Inhibitor assay to reduce the risk of serious injury from one of the highest risk outpatient drug treatments.”
Whether the FDA, notorious to consumer advocacy groups who claim the agency drags its heels over patient safety issues and is beholden to drug manufactures, acts on this request remains to be seen. Read more about the Pradaxa lawsuits starting.
Consider this FDA response to an inquiry from a Detroit television news team, which produced an investigative report about the dangers of Pradaxa bleeding in which an FDA spokesperson cites bleeding as “a well-recognized risk:”
“As explained in our drug safety information about Pradaxa, Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly. Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes. The risk of bleeding is a well-recognized risk of anticoagulant drugs. Pradaxa provides an important health benefit when used as directed.”