New documents have revealed that employees of the pharmaceutical manufacturer Boehringer Ingelheim were worried that sales of Pradaxa could have been damaged if it gained knowledge that users of the popular blood thinner could have required additional testing.
Pradaxa was approved for sale in U.S. markets in 2010. Since then, lawsuits have been mounting against the manufacturer over allegations that the blood thinner has caused the deaths of thousands of patients.
The new documents in the Pradaxa lawsuit were unsealed last Thursday by Judge David R. Herndon.
According to the New York Times, the drug has been responsible for more than $2 billion worth of sales in the United States and prescribed to 850,000 patients. Regrettably, NYT also notes that the drug has been tied to more 1,000 deaths.
Despite this, Boehringer Ingelheim has cited that the FDA has upheld the safety of Pradaxa. However, as we have noted before, the FDA’s study regarding the safety of Pradaxa has been called into question by experts.
The internal emails between employees expressed that patients could benefit from continued blood monitoring, that Boehringer Ingelheim could have developed the necessary testing, but instead, it was decided that the company would not develop such a test.
Pradaxa has been promoted as a “safe” alternative to the drug warfarin.
However, the emails express concern that the company’s internal findings would produce complications in discussions with regulatory bodies.
“This publication will more harm than be useful for us, neither in the market but especially harmful in discussions with regulatory bodies.”
Unlike the drug that Pradaxa has practically replaced, warfarin, Pradaxa has no antidote to counteract the anticoagulating effect.
“Can’t this be avoided?” an email read.