Pradaxa feared to increase risk for fatal internal bleeding, cerebral hemorrhage, bleeding ulcer and heart attack.
Pradaxa is now tied in first place as the drug most often linked to FDA MAUDE adverse event reports filed in 2011. QuarterWatch reported that these filings show Pradaxa ranks among the highest risk drug treatments ever. The FDA has received reports of 542 deaths and 3,781 serious or harmful events in the US in 2011.
In December 2011, the Food and Drug Administration (FDA) issued a public safety announcement regarding bleeding incidents that had been reported by patients taking Pradaxa. According to a study published in the Archives of Internal Medicine In January of 2012, Pradaxa use was linked to a thirty-three percent increase for risk of heart attack. In May of this year, it was the European Medicines Agency that acknowledged fatal bleeding was linked to Pradaxa and encouraged better guidance for its use. The FDA noted the bleeding risks due to Pradaxa use are serious due to the number of reported deaths.
Pradaxa was first approved by the FDA in October 2010 for the prevention of strokes in patients affected by atrial fibrillation. Pradaxa was formulated as a possible replacement for warfarin, also known as Coumadin and Jantoven, in the long term treatment of atrial fibrillation. A little over one year later, researchers began to produce documentation linking Pradaxa to harmful bleeding events that were not immediately communicated to doctors and patients.
Manufacturer Boehringer Ingelheim GmbH may have rushed Pradaxa through mandatory clinical trials to speed the FDA approval process which would allow the drug maker to beat two competing warfarin replacement drugs onto the market. In April, Pradaxa's early arrival helped it to became known as a "blockbuster" drug. Pradaxa generated estimated annual sales of over one billion dollars.
Boehringer's negligent rush to the market means a very dangerous drug has reached millions of unsuspecting doctors and patients, causing a situation where thousands of injuries and deaths may occur. At the same time this knowledge is being made public, the makers of Pradaxa are heavily promoting their drug as a new and improved alternative to warfarin.
While numerous studies were conducted to establish warfarin as a safe and effective drug, Pteh makers of Pradaxa have conducted just one. While the single study appears to support a claim of 35% reduction in stroke when compared to warfarin, the study revealed additional data. Use of Pradaxa carried a statistically significant increase risk of gastrointestinal bleeding over those taking warfarin. Boehringer argued the increased risk of bleeding was "outweighed" by a lowered risk of stroke.
Pharmaceutical regulators such as the FDA are starting to question whether this claim can be substantiated. The sole Pradaxa study was seen as plagued by data integrity errors. Experts claim the design of the study was subject to bias. Accusations have been that 18 of the study's 20 named authors revealed a financial conflict of interest due to ties with the makers of Pradaxa.
The most important flaw of the study was that it did not make clear the fact that Pradaxa has no known reversing agent. This means in a bleeding situation, a physician has no means to stop the internal bleeding of a patient that has been using Pradaxa. The blood=thinning effect of warfarin on the other hand can be quickly and effectively reversed in the event of an emergency bleeding event.
Among the serious side effects reported are:
- Internal bleeding
- Cerebral hemorrhaging
- Unusual bruising or bleeding / hemorrhaging
- Bleeding that is severe or you cannot control
- Nose bleeding that happens often
- Vomiting blood or vomit that looks like coffee grounds.
- Pink or brown urine
- Red or black stools (looks like tar)
- Unusual bleeding from the gums
- Bruises that happen without a known cause or that get larger
- Menstrual or vaginal bleeding that is heavier than normal
- Coughing up blood or blood clots