German pharmaceutical giant Boehringer-Ingelheim (BI) is trumpeting the news across the world: their flagship product, Pradaxa (dabigatran), approved in 100 countries around the world for stroke prevention and other life-threatening heart conditions, has netted the company $807 billion in sales in just the first six months of 2013!
The company has also announced ongoing research to, as corporate senior vice president Klau Dugi says, “deepen our understanding of the treatment’s benefit/risk profile to address evolving patient needs and benefit the cardiovascular community as a whole.” The company is planning “new clinical trials where we see unmet patient need,” Dugi says. (According to an article in Forbes, one clinical trial has not produced the results BI was hoping for; Pradaxa has been proven an inappropriate treatment for patients with prosthetic heart valves.)
In short, perhaps there are even more uses for Pradaxa that can generate even bigger sales for Mr. Dugi and company.
Currently, there are twelve clinical trials being conducted around the world – sponsored by Boehringer-Ingelheim, of course.
Few in the medical community would argue that Pradaxa is highly effective at preventing strokes in high-risk patients. It has certain advantages over warfarin, primarily in that Pradaxa has fewer interactions – a serious concern in geriatric patients who often take many different prescriptions.
This isn't the issue.
The problem is that if a patient starts bleeding while Pradaxa is in his or her system, there is virtually no way to stop it. Several patients have bled to to death because there is no antidote. There have been a some mention in The Pharma Letter and Wall Street Journal that BI has presented “new preclinical research” on an “investigational reversal agent” tested in laboratory rats, but this research doesn't seem to be moving forward quite as quickly. In the meantime, the lawsuits and liabilities keep mounting; one of the most recent plaintiffs to join the multi-district litigation is seeking $1 million in economic, non-economic and punitive damages against BI on grounds that warnings of the drug's side effects were inadequate.
Husten, Larry. “Disappointing Results with Boehringer's Pradaxa for Mechanical Valves.” Forbes, 1 September 2013.
Lawson, Ava. “Pradaxa Wrongful Death Lawsuit Demands $1 Million in Damages.” Injury Lawyer News, 28 August 2013.
N/A. “Boehringer Ingelheim Announces Plans to Expand Body of Evidence with Novel Cardiovascular Research Supporting Pradaxa®.” PRNewswire, 3 September 2013.
N/A. “Boehringer Ingelheim to Present New Pradaxa® Data at ESC Congress 2013. Wall Street Journal Market Watch, 23 August 2013.
N/A. “Boehringer Ingelheim Plans to Expand Body of Evidence for Pradaxa.” The Pharma Letter, 4 September 2013
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