As of 8/27/2012, 17,254 reports of a serious adverse event where Pradaxa was identified as the primary suspect drug causing the event had occurred.
According to voluntary reports to the FDA from health professionals and consumers, in 2011, Pradaxa surpassed all other monitored drugs in several categories, including overall number of reports (3,781), deaths (542), hemorrhage (2,367), acute renal failure (291) and stroke (644).
Pradaxa is a prescription blood-thinning medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation. We expect the number of deaths and life-altering side effects to climb as investigations into Pradaxa continue.
If you have experienced side effects such as:
- Unusual Bruising
- Blood in the urine or stool
- Vomiting Blood
Please contact your doctor to consider your medical options. You may also have a claim against Boehringer Ingelheim Pharmaceuticals, and we would be happy to discuss it with you at no charge.
Boehringer Ingelheim’s Annual Report boasts their guiding principle as “Be First-Be Best- Be Focused” and it now appears that they should add “Be Careful.”
Although Pradaxa has been on the market for only a year, its hype began long before. Prior to approval Boehringer Ingelheim ran “informational” commercials about atrial fibrillation.
Following the media hype, Pradaxa gained momentum as the result of the “RE-LY Clinical trial” sponsored by Boehringer Ingelheim Pharmaceuticals. The RE-LY trial concluded that vitamin K antagonists such as warfarin (or Coumadin - on the market for more than 50 years) are cumbersome to use, because of their multiple interactions with food and drugs, and they require frequent laboratory monitoring.
Not surprisingly, the clinical trial sponsored by Boehringer Ingelheim suggested that there was a need for a new anticoagulant agent that could be a therapeutic simplification. Step in Pradaxa – predicted to become one of the leading therapies in the atrial fibrillation drug market, garnering blockbuster sales of $1.3 billion by 2018.
Unfortunately, there are too many incidents where products prove to be more dangerous than the company-sponsored studies indicated, as the current death count appears to indicate.
TorHoerman Law will continue to monitor the investigation into the safety and efficacy of Pradaxa.