Report Suggests Boehringer Withheld Crucial Info on Pradaxa Dose Monitoring

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Clik here to view.An investigation conducted by the British Medical Journal (BMJ) finds that Pradaxa manufacturer Boehringer Ingelheim withheld crucial information from health regulators regarding the safety of its best-seller blood thinning drug dabigatran (Pradaxa).

Entitled, “Dabigatran: how the drug company withheld important analyses,” the report suggests that Boehringer failed to disclose to European or United States regulators its own findings on how to prevent Pradaxa bleeding events through proper dosage and plasma-level monitoring.

The theory is that Boehringer withheld this data since Pradaxa’s purported ease of dosing and lack of monitoring was one of its main advantages over warfarin, which required close maintenance therapy monitoring to avoid major hemorrhaging events.

The BMJ’s reports contend that Boehringer kept secret that some of its researchers felt that monitored Pradaxa  dosing “has the potential to provide patients an even better efficacy and safety profile than fixed-dose dabigatran and also a better safety and efficacy profile than a matched warfarin group.”

Internal documents on Pradaxa bleeding events

According to investigations editor for BMJ, Deborah Cohen, “[Boehringer’s] internal documents show how the company had produced extensive analyses that show how that bleeding risk may be reduced. The company found that if the plasma levels of the drug were measured and the dose was adjusted accordingly major bleeds could be reduced by 30-40% compared with well controlled warfarin. The adjustment would have little or no effect on the risk of ischaemic stroke. It has also identified the plasma levels at which the dose adjustment should occur to reduce the risk of a major bleed.”

The company’s analysis concluded that optimally-used dabigatran had the potential to provide patients an even better safety profile than fixed dose Pradaxa and also a better safety and efficacy profile than warfarin.

Boehringer maintains the safety of Pradaxa and released the following statement following the BMJ report, “The analysis did not provide a reliable prediction of patient outcomes, and therefore we did not share the simulation with FDA or EMA… The FDA has publicly reported its own post-marketing analysis, concluding that dabigatran’s post-marketing bleeding rates do not appear to be higher than [those with] warfarin.”

Monitored dosing and a clear market advantage

Since gaining FDA approval in 2010, Pradaxa has garnered the lion’s share of sales for prescription treatment of non-valvular atrial fibrillation (AF). Boehringer marketed their new drug as being substantially easier than warfarin, since the medication didn’t entail strict monitoring or blood tests. Those who are taking warfarin must have their blood tested once or twice weekly in the early stages of treatment to allow for dosage adjustments.

While Pradaxa proved effective at reducing incidence of stroke in AF patients, it’s anticoagulant effects were virtually impossible to stop, unlike warfarin-induced bleeding events, which could be controlled with doses of Vitamin K. Uncontrolled Pradaxa bleeding events have been associated with more than 580 deaths in the U.S., according to the Institute for Safe Medication Practices.

Thousands of patients who suffered GI bleeds and life-threatening hemorrhages have taken their claims to court, seeking compensation from Boehringer Ingelheim.

Boehringer negotiates $650 million Pradaxa settlement

On May 28, 2014, Boehringer Ingelheim announced it was settling litigation over Pradaxa side effects and uncontrolled bleeding to the tune of $650 million. The accord will resolve some 4,000 cases against the drug maker that had been pending before U.S. District Judge David R. Herndon in Illinois federal court.

Legal counsel for the plaintiffs estimates that each claimant should expect to secure roughly $165,000 in monetary damages. The settlement takes potentially lengthy and expensive litigation out of the equation for both sides, should all plaintiffs accept the terms of the accord. The pharmaceutical giant admits no wrongdoing or misconduct in the design or manufacture of its blockbuster anticoagulant, and the agreement was reached just months before bellwether Pradaxa trials were to commence.

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