According to a news release issued in June, a published analysis showed Pradaxa offered a serious reduction in the risk of stroke versus warfarin in patients with non-valvular atrial fibrillation.
Boehringer-Ingelheim, the German drugmaker responsible for Pradaxa, points to the RE-LY clinical trial. Pradaxa was superior to warfarin when stopped 24 to 48 hours before surgery in reducing major bleeding, according to a news release by the company. It is never a good idea to stop an oral anticoagulant (OAC) suddenly but sometimes it is necessary before a scheduled surgery. With Pradaxa 150 mg, nearly half of the patients underwent surgery within 2 days after stopping the OAC versus 11 percent on warfarin.
What is not spelled out in this press release is that there is no reversal agent for Pradaxa. Here is what the label suggests doctors tell patients about this dangerous drug.
* Tell patients to take PRADAXA exactly as prescribed.
* Remind patients not to discontinue PRADAXA without talking to the health care provider who prescribed it.
* Keep PRADAXA in the original bottle to protect from moisture. Do not put PRADAXA in pill boxes or pill organizers.
* When more than one bottle is dispensed to the patient, instruct them to open only one bottle at a time.
* Instruct patient to remove only one capsule from the opened bottle at the time of use. The bottle should be immediately and tightly closed.
* Advise patients not to chew or break the capsules before swallowing them and not to open the capsules and take the pellets alone.
And Pradaxa is tops in another way – Tops in the FDA’s Adverse Events Reports for March 2011 for serious and fatal complications involving uncontrollable bleeding in the head, rectum, gastrointestinal bleeding and strokes.
The Institute for Safe Medication Practices says Pradaxa also topped the list in serious and fatal complications last year.
Approved in October 2010, Pradaxa was heavily promoted as being superior to warfarin (Coumadin) and more convenient to use. However left off of the accolades was the fact that there is no way to reverse the blood-thinning properties of Pradaxa in case the user experiences trauma such as a fall or car accident. Coumadin users have a fallback position – they can be injected with vitamin K to stop bleeding in the case of an accident.
An inability to stop bleeding can prove fatal for the older population, according to a story last year in the Archives of Internal Medicinem, and indeed there have been more than 500 reports of excessive bleeding and at least 120 deaths just from October 2010 to March 2011. Since then there have been more than 900 reports to the FDA of gastrointestinal bleeding, 300 reports of rectal bleeding and more than 200 reports of cerebrovascular bleeding and 500 deaths.
Because of the large number of lawsuits and the fact that the drug company continues to leave this dangerous and defective pharmaceutical on the market, motions have been filed to consolidate the growing number of cases into an MDL or multidistrict litigation.