Overview: A QuarterWatch report by the Institute for Safe Medication Practices (ISMP) finds that the U.S. Food and Drug Administration (FDA) received more fatal reports with Pradaxa (dabigatran) than any other drug in 2011. Boehringer Ingelheim’s anticoagulant led several other categories as well, including hemorrhaging, acute renal failure and stroke.
- ISMP QuarterWatch report cites 3,781 Pradaxa-linked events reported to the FDA last year
- Pradaxa had the largest number of reports, but was also associated with the highest rate of hemorrhage (2,367), acute renal failure (291), and stroke (644)
- Pradaxa, which was approved in 2010 to prevent blood clot and stroke in AF patients, has raised significant safety concerns because there is no antidote to reverse its anticoagulant effects
Product: Pradaxa (dabigatran)
Manufacturer: Boehringer Ingelheim Pharmaceuticals
Side Effects & Complications
- Cerebral hemorrhaging
- Gastrointestinal (GI) hemorrhaging
- All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas
ISMP QuarterWatch Report
The ISMP QuarterWatch Report is based off data from the FDA’s Adverse Event Reporting System (AERS), or MedWatch reports. The MedWatch system receives adverse event data through manufacturers and voluntary reports from patients and healthcare professionals. In 2011, there were a total of 179, 855 reports; 88 percent were submitted by manufacturers and 12 percent via patients and professionals.
According to the QuarterWatch, there were more reports for Pradaxa than for any other drug last year, with 3,781 serious adverse events reported to the FDA. The ISMP pointed out that the blockbuster drug “accounted for so many reports of serious adverse events that was prominent in several different categories” with 542 cases of patient death, 2,367 cases of hemorrhaging, 291 cases of acute renal failure and 644 cases of stroke. Pradaxa may also be linked to 15 cases of liver failure.
Pradaxa Bleeding Concerns
Pradaxa is part of a new class of anticoagulants known as “direct thrombin inhibitors”. The medication and its competitors, Eliquis and Xarelto, are a modern alternative to Coumadin (warfarin). Warfarin has been on the market for 50 years, but its food and drug interactions, along with the need for frequent blood tests, are often an inconvenience for patients. Pradaxa and its rival drugs do not have these drawbacks, but there is also no antidote if the patient begins to hemorrhage. The effects of warfarin, however, can be reversed with vitamin K.
The lack of a reversal agent makes even minor falls risky. This concern was highlighted in March, when the Journal of Neurosurgery published a case report of an elderly Pradaxa patient who died after a ground-level fall in his home.
Pradaxa was approved in 2010 to prevent blood clots and stroke in patients with atrial fibrillation (AF). The ISMP first raised concerns about the drug in February 2011, when a patient with chronic kidney disease suffered gastrointestinal bleeding after taking Pradaxa. Japanese and European regulators addressed similar concerns that summer and fall respectively, and the European Medicines Agency (EMA) decided that a patient’s renal function should be assessed before starting treatment with Pradaxa, especially in elderly patients. In November, the EMA database received over 250 reports of Pradaxa-linked deaths, prompting the FDA to launch a safety review in December.