It was just a few short weeks ago that we reported that a Canadian Watchdog Group was questioning whether or not the drug Pradaxa was given approval for consumers way too quickly all across the world. (Be sure to check out that article here!) And, now in recent news, the drug is being linked to 50 deaths across the world.
Pradaxa, an oral direct thrombin inhibitor, is approved for stroke prevention in patients with atrial fibrillation in more than 50 countries, including the U.S., Canada, Japan, and the member states of the European Union. It is also approved in some countries (not the U.S.) for the prevention of venous thromboembolism (VTE) in patients undergoing total hip or knee replacement.
However, at stated these approvals are not coming without some controversy. There are reports that the anticoagulant dabigatran (Pradaxa) has been linked to about 50 deaths from bleeding in atrial fibrillation patients. Yet, the drug’s manufacturer said the safety profile is where it should be.
“The clinical effectiveness and favorable safety profile of Pradaxa is positive and remains unchanged in light of recent reports about fatal cases of bleeding in the media,” Boehringer Ingelheim said in a statement.
Boehringer was responding to an article in the German publication Die Zeit, which reported the drug was associated with “deadly side effects.”
Reinhard Malin, PhD, a spokesperson for Boehringer was quoted in Die Zeit as confirming the association, and said that 50 deaths worldwide was probably in the right range.
“It’s difficult to give one figure as any death has to be validated and this is an ongoing process,” Malin told MedPage Today. “The number 50 seems reasonable, but I don’t have the exact figure.”
According to a report from Reuters, Boehringer Ingelheim maintains that the number of deaths fell within expectations from the clinical study that led to Pradaxa’s market approval.
Yet, recently, regulators in some countries have become more concerned about possible Pradaxa side effects. On October 28, for example, Boehringer Ingelheim agreed to notify European doctors that patients older than 75 and those with renal impairment should undergo kidney checks every year. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding.
In August, regulators in Japan – where the drug is sold as Prazaxa – told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 of the almost 64,000 mainly elderly patients taking it there suffered heavy bleeding. In New Zealand, 122 cases of side effects in Pradaxa patients have been reported to the Centre for Adverse Reactions Monitoring (CARM), of which two out of five involved bleeding.
According to a report from Bloomberg News, some of those 50 deaths occurred in Germany, while 14 were reported in Japan since August. In Japan, the deaths occurred because patients couldn’t sufficiently excrete the blood-thinner.
In its prepared statement, the company said, “Serious bleeding events can and do occur, with all anticoagulants including Pradaxa. Importantly, the bleeding events and fatal bleedings reported to date are considerably fewer than expected based on the trial data that support the use of Pradaxa in clinical practice,” citing two studies.
I, for one, resort back to what the Canadian Watchdog group is saying, and that is, “Are we sure this drug was not given an approval too quickly“?! Sounds to me, like they are surely justified in their questioning!
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