Boehringer Ingelheim, Germany-based drugmaker of anticlotting drug Pradaxa, filed an application to the U.S. Food and Drug Administration (FDA) for “additional marketing approvals.” This filing is part of a string of large-scale marketing expansions attempted by the company.
Earlier this year, Boehringer Ingelheim submitted a similar application to the European Medicines Agency (EMA) that requested the extension of Pradaxa’s use to treat acute deep vein thrombosis. Pradaxa was approved by the FDA in 2010 to treat atrial fibrillation.
Since its release, Pradaxa has been connected to over 500 deaths in America, deaths which helped rake in over “$1 billion in sales for its maker.” Pradaxa replaced warfarin, which has been on the market for 60 years with dangers or harm that can be reversed or prevented by offering patients vitamin K, an option not available with Pradaxa.
“The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” said Dr. Richard H. Schmidt, an associate professor at the University of Utah.
Boehringer Ingelheim has gotten into several legal scrapes before. They paid millions in a suit for illegally promoting unapproved uses of its products, and has also seen allegations of paying kickbacks to doctors for prescribing their medicine. Many dangerous drugs, like Pradaxa, are forced through the FDA approval process by politicians and Big Pharma bureaucrats without sufficient information about the drug’s effects.
“Boehringer Ingelheim convinced the FDA to get this drug through the pipeline as quickly as possible.” said Ned McWilliams, a pharmaceutical litigation attorney with the Levin, Papantonio law firm. “They convinced the FDA that there was an emergency need for this drug and should be approved in six months. The only other drugs that are approved that quickly are actual emergency drugs for people who are on their deathbed.” Because the drug was so dangerous, Boehringer Ingelheim issued a voluntary Pradaxa recall of a “single manufacturing lot.”