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The BMJ has set off a kerfuffle–and a Twitter campaign–over the safety of Boehringer Ingelheim’s blockbuster anticoagulant Pradaxa. With three articles and an editorial devoted to the drug in its latest issue, the journal not only advocates regular blood tests for Pradaxa patients, but accuses the company of burying data that would have backed that testing from the get-go.
Video : Dr Charles de Wet, Boehringer Ingelheim response to BMJ
Health guidelines in Europe and North America recently began recommending Pradaxa and similar drugs for stroke patients with non-valvular atrial fibrillation, in part, because the drugs are marketed as not needing monitoring or dose adjustment, unlike older treatments such as warfarin.
However, recently obtained internal documents show Boehringer withheld information from regulators about the potential benefits of monitoring and adjusting the dose, according to BMJ investigations editor Deborah Cohen.
The company also withheld analyses calculating how many major bleeds dose adjustment could prevent, the BMJ reports.
Boehringer found that if the plasma levels of the drug were measured and the dose was adjusted accordingly, major bleeds could be reduced by 30 to 40 per cent compared with well controlled warfarin.
US$650 million payout
Last month Boehringer Ingelheim announced it would pay US$650 million in a “comprehensive settlement” of US lawsuits over Pradaxa, while maintaining its safety claims.
Pradaxa has been plagued by reports of excessive bleeding since its approval, but regulatory agencies, including Medsafe and Pharmac in New Zealand, have backed the drug’s benefit–risk profile.
Boehringer says it has provided complete data
In response to the BMJ article, Boehringer has released a written statement saying it has provided regulators with the complete data set and analyses of clinical evidence demonstrating the efficacy and safety profile of Pradaxa.
The FDA and European Medicines Agency have affirmed RE-LY (Randomised evaluation of long-term anticoagulant therapy trial) conclusions and stated that Pradaxa provides an important health benefit when used as directed, Boehringer says.
“On May 13, 2014, in one of the largest real-world analyses of its kind, the US Food and Drug Administration (FDA) once again reaffirmed the positive efficacy-safety profile of Pradaxa when it issued results from this study in clinical practice. This included more than 134,000 patients, who were 65 years or older and were not monitored.”
However, Boehringer also notes that like the RE-LY study, the FDA study found an increased risk of major gastrointestinal bleeding with use of Pradaxa compared with warfarin.
“But the most important results are that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death, than warfarin,” Boehringer says.
Agencies/Canadajournal
