Since the FDA approved the blood-thinner Pradaxa in 2010 the drug has
come under scrutiny for adverse bleeding events. In the United States the
drug has exceeded $2 billion in sales. But out of the 850,000 patients it has
been prescribed to it has also been linked to more than 1,000 deaths.
When it was first approved, Pradaxa was the first in a new category of
replacements for Warfarin (Coumadin), the decades-old drug used to prevent
strokes in people with a heart-rhythm disorder known as atrial fibrillation.
Patients prescribed Warfarin needed to be monitored closely, undergoing
frequent blood tests to ensure the drug was working. Pradaxa required
no monitoring and in early tests it appeared to be better than Warfarin at
But almost immediately after the drug started being prescribed doctors
and patients became concerned about its safety. In 2011, 542 deaths were
reported to the FDA in which Pradaxa was suspected as the cause. The
nonprofit Institute for Safe Medication Practices listed Pradaxa as the
leading cause of injury or death out of the more than 800 drugs it monitors.
Most alarming to critics is that Pradaxa was released with no antidote
available to stop its side effects. Warfarin could be reversed with vitamin
K or other substances, and while still deadly at times, still gave doctors
options. Pradaxa offered no antidote or options and doctors described being
helpless as they watched patients bleed out in front of them.
Now it has been reported (New Emails in Pradaxa Case Show Concern
Over Profit, Feb. 7, 2014), that employees of Boehringer Ingelheim, the
German drug maker who makes Pradaxa were privately expressing concern
whether sales would suffer if patients knew they might need to undergo
regular testing for safety reasons.
The company e-mails were ordered released by Chief Judge David R.
Herndon, of the United States District Court in East St. Louis. Herndon is
overseeing thousands of lawsuits filed by patients and families who claimed
Boehringer Ingelheim failed to properly warn them about the risks of taking
In light of early concerns after Pradaxa’s release, Boehringer Ingelheim had
conducted internal testing that showed some patients using the drug would
benefit from closer monitoring of their blood. By monitoring absorption
levels of the drug, the safety of the patients would be better ensured. These
conclusions caused a robust discussion within the company, with employees
expressing concern that – since no testing was a major marketing point – by
recommending testing of patients sales would suffer.
What is abundantly clear in all the company e-mails released is that the
employees of Boehringer Ingelheim were – in spite of over 1000 deaths
linked to Pradaxa – more concerned with sales and profit than they were
about the safety and welfare of the patients they served.