Boehringer Ingelheim launched a flurry of twitter activity to counter last week’s UK news report claiming regular blood tests would reduce the risk of severe bleeding among Pradaxa patients.
Boehringer Ingelheim’s blockbuster blood-thinning drug, Pradaxa (dabigatran etexilate), is not without its share of controversy. Much revolves around one of the key touted benefits of the warfarin replacement – that patients do not need the regular blood tests that those on the older drug require.
A report published on Wednesday in the British Medical Journal, argues that blood tests could reduce major bleeds among patients taking the drug. The article claims that levels of Pradaxa in the blood of patients can vary more than fivefold, and that these amounts are linked to potentially fatal bleeding.
Once in widespread use, Pradaxa became the subject of numerous reports of dangerous, uncontrollable internal bleeding. These events were often life-threatening because no antidote existed to counteract the effect – although the manufacturer is developing one.
Having been prescribed to over 850,000 individuals in the US, Pradaxa has been alleged to have played a significant role in at least 1,000 deaths.
Many of the lawsuits hinge on the allegation that the manufacturer negligently failed to warn consumers of known risks, marketed a defectively designed and manufactured product, and that the labelling was insufficient and misleading.
Boehringer’s pharmacovigilance practices were also commonly criticised, especially an alleged lack of appropriate and thorough follow-up investigations when adverse event reports emerged.
The company has continued to vigorously defend its product, disputing the BMJ findings, saying that "the totality of scientific evidence does not support dosing decisions for Pradaxa based on blood levels."
It produced a flurry of tweets the day before a critical UK Channel 4 news article on the BMJ findings was due to be broadcast. These included comments like “A two-year, 18,000 person trial does not constitute 'fast-tracking of approval'."
Boehringer says it is concerned that patients could become convinced to stop taking their drugs and greatly increase their risk of stroke.
At the end of May, the company agreed to pay $650 million to settle outstanding US litigation concerning the product. The settlement is expected to resolve around 4,000 pending cases, including over 2,350 federal lawsuits and was made to prevent the distraction and uncertainty of the legal action.
In May, US FDA investigated the drug and its side effects, concluding that it continues to have a “favorable benefit to risk profile,” and that there were no required changes to its labelling.
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