prescription drugs come with a lengthy list of side effects and warnings. But one drug maker
is being called out for failing to warn patients about some very specific
risks that may have contributed to 1,000 deaths in recent years. Now,
the maker of the blood thinner Pradaxa is facing thousands of lawsuits.
Legal documents filed recently suggest some employees of the drug manufacturer Boehringer
Ingelheim, sought to quash information about Pradaxa's risks. Thousands
of lawsuits have been filed on behalf of patients and their families who
suffered various adverse effects, claiming their injuries could have been
prevented had they known the risks existed.
Pradaxa's selling point in question
Pradaxa is a blood-thinning medication used to prevent strokes and blood clots.
It and other similarly new drugs have been promoted as alternatives to
the leading blood thinner, warfarin, which has been on the market many
years. One of the downfalls of warfarin is that it requires patients to
monitor their blood levels and diet on a regular basis. It's a highly
interactive drug, requiring patients to have frequent blood tests and
checkups while on it. Pradaxa was offered as a no-blood-test alternative.
Being able to take a powerful blood-thinner without regular blood tests
was a big selling point for Pradaxa. In the development stages, Boehringer
sought to make a drug that wouldn't require a regular check-in with
a doctor. It's this, in part, that led to the current legal hot water
that they're in.
An internal research paper, made public last week, shows there were questions
about Pradaxa's safety, and even the suggestion that some patients
would benefit from regular blood tests. The study's author, clinical
program director Paul A. Reilly, said that while some patients absorb
too little of the drug for it to work effectively, others absorb too much,
putting them at risk of internal bleeding. Also revealed in court documents
were the emails, memos, and internal presentations from other employees
at Boehringer that essentially sought to reword or even trash the research
results before they were released.
The notion that Pradaxa patients would need regular blood tests undermined
the marketing goal of the drug: to sell the new pharmaceutical to patients
who didn't want to be troubled with the high-maintenance of competitors
Without proper warnings, Pradaxa produced deadly results
Pradaxa hit the market in 2010, without any warnings of necessary blood
tests. It's brought in more than $2 billion dollars in U.S. sales,
a financial success. But, since its launch, 1,000 people have died from
bleeding caused by the drug. They are deaths that many believe could have
been prevented with regular blood tests.
Warfarin, the now-generic predecessor to Pradaxa, not only required blood
tests, but there was also an antidote to reverse the blood-thinning effects
in case a patient began exhibiting dangerous symptoms. For Pradaxa,
there is no antidote.
As the research regarding Pradaxa circulated through the Boehringer offices,
employees questioned the need to release it to the public. They expressed
concern over the wording and how the research could make things "extremely
difficult" for the company to convince regulators that no blood tests
were needed. The reaction was generally negative-not because employees
were concerned about the risks to patients, but because they were concerned
More than 850,000 people have received prescriptions for Pradaxa. It remains
on the market and Boehringer stands by its claims of safety.