A promising drug with a small flaw – you might bleed to death


Walter Daumler with a photograph of his sister Doris Daumler – on Pradaxa and died in May

Dr. Bryan A. Cotton, a trauma surgeon in Houston, had not heard much about the new anticlotting drug Pradaxa other than the commercials he had seen during Sunday football games.

Then people using Pradaxa started showing up in his emergency room. One man in his 70s fell at home and arrived at the hospital alert and talking. But he rapidly declined. “We pretty much threw the whole kitchen sink at him,” recalled Dr. Cotton, who works at Memorial Hermann-Texas Medical Center. “But he still bled to death on the table.”

Unlike warfarin, an older drug, there is no antidote to reverse the blood-thinning effects of Pradaxa.

“You feel helpless,” Dr. Cotton said. The drug has contributed to the bleeding deaths of at least eight patients at the hospital. “And that’s a very bad feeling for us.”

Pradaxa has become a blockbuster drug in its two years on the market, bringing in more than $1 billion in sales for its maker, the privately held German drug maker Boehringer Ingelheim.

But Pradaxa has been linked to more than 500 deaths in the United States, and a chorus of complaints has risen from doctors, victims’ families and others in the medical community, who worry that the approval process was not sufficiently rigorous because it allowed a potentially dangerous drug to be sold without an option for reversing its effects.

Pradaxa is an example, some critics say, of what can happen when a drug that performs well in tightly controlled trials is released into the messy world of real-life medicine. Boehringer Ingelheim said it was working on developing an antidote but that even without one, patients in a large clinical trial died at roughly the same rate as those who were taking warfarin.

The Food and Drug Administration released a report on Friday that found that the drug did not show a higher risk of bleeding than for patients taking warfarin. The report did not address the lack of an antidote for Pradaxa.

Think that’s an oversight? Or perhaps the FDA deliberately didn’t address the question of an antidote publicly – because they don’t care to.

Either flavor, the report sucks. Allowing medication with significant benefits into the marketplace – if you never acquire a bleeding injury – is absurd. Guaranteeing death while increasing survival odds in another part of the equation is pure and simple madness. Madness driven by profits.

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