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By KATIE THOMAS
http://www.nytimes.com/2012/11/03/bu...gewanted=print
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.
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.
“The problem is that the people that prescribe this, as a general rule, are cardiologists and family practitioners,” said Dr. Mark L. Mosley, director of the emergency room at Wesley Medical Center in Wichita, Kan. “The people that see the harm are your E.R. docs and your trauma docs.”
Critics say that at least until an antidote is found, better disclosure or more limited use of Pradaxa may be preferable. Patients’ lawyers have begun turning their attention to the drug. More than 100 lawsuits have been filed in federal courts and lawyers say thousands more are expected.
When the F.D.A. approved Pradaxa in October 2010, the drug was hailed as the first in a new category of replacements for warfarin, the nearly 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation.
Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that it is working.
Pradaxa required no such monitoring and, compared with warfarin, appeared to be better at preventing strokes.
Sales of the drug took off. By the end of 2011, after just over a year on the market, 17 percent of patients with atrial fibrillation were being prescribed Pradaxa, compared with 44 percent for warfarin, according to a study released in September. About 725,000 patients in the United States have used the drug, according to the F.D.A.
But almost as soon as doctors started prescribing Pradaxa, concerns surfaced about its safety. Pradaxa was identified as the primary suspect in 542 patient deaths reported to the F.D.A. in 2011, and was linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices, a nonprofit based in Pennsylvania that monitors medicine safety.
Dr. Mosley said he found it “shocking, just shocking” that the F.D.A. approved Pradaxa, which is also called dabigatran, even though no antidote was available.
In a statement, the F.D.A. said, “the lack of an antidote notwithstanding, dabigatran was superior to warfarin in preventing strokes in a large clinical trial. The rates of bleeding were similar.” In the study it released on Friday, the F.D.A. examined health insurance claims and hospital data and reached a similar conclusion.
Warfarin, which is also known by the brand name Coumadin, can often be reversed by giving a patient vitamin K or other substances. Warfarin, too, can be deadly but, doctors said, they at least have options.
“The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” said Dr. Richard H. Schmidt, an associate professor of neurosurgery at the University of Utah, who treated an 83-year-old man who died from bleeding and was using Pradaxa.
Boehringer Ingelheim recommends treating bleeding patients with dialysis to help flush the drug from the body, although it notes that “the amount of data supporting this approach is limited.”
Several doctors said that option was not realistic. “People that are bleeding to death aren’t going to tolerate being put on dialysis,” Dr. Cotton said.
Critics say that at least until an antidote is found, better disclosure or more limited use of Pradaxa may be preferable. Patients’ lawyers have begun turning their attention to the drug. More than 100 lawsuits have been filed in federal courts and lawyers say thousands more are expected.
When the F.D.A. approved Pradaxa in October 2010, the drug was hailed as the first in a new category of replacements for warfarin, the nearly 60-year-old drug used to prevent strokes in people with a heart-rhythm disorder known as atrial fibrillation.
Warfarin requires careful monitoring of a patient’s diet and drug regimen, and frequent blood tests to ensure that it is working.
Pradaxa required no such monitoring and, compared with warfarin, appeared to be better at preventing strokes.
Sales of the drug took off. By the end of 2011, after just over a year on the market, 17 percent of patients with atrial fibrillation were being prescribed Pradaxa, compared with 44 percent for warfarin, according to a study released in September. About 725,000 patients in the United States have used the drug, according to the F.D.A.
But almost as soon as doctors started prescribing Pradaxa, concerns surfaced about its safety. Pradaxa was identified as the primary suspect in 542 patient deaths reported to the F.D.A. in 2011, and was linked to more reports of injury or death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices, a nonprofit based in Pennsylvania that monitors medicine safety.
Dr. Mosley said he found it “shocking, just shocking” that the F.D.A. approved Pradaxa, which is also called dabigatran, even though no antidote was available.
In a statement, the F.D.A. said, “the lack of an antidote notwithstanding, dabigatran was superior to warfarin in preventing strokes in a large clinical trial. The rates of bleeding were similar.” In the study it released on Friday, the F.D.A. examined health insurance claims and hospital data and reached a similar conclusion.
Warfarin, which is also known by the brand name Coumadin, can often be reversed by giving a patient vitamin K or other substances. Warfarin, too, can be deadly but, doctors said, they at least have options.
“The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” said Dr. Richard H. Schmidt, an associate professor of neurosurgery at the University of Utah, who treated an 83-year-old man who died from bleeding and was using Pradaxa.
Boehringer Ingelheim recommends treating bleeding patients with dialysis to help flush the drug from the body, although it notes that “the amount of data supporting this approach is limited.”
Several doctors said that option was not realistic. “People that are bleeding to death aren’t going to tolerate being put on dialysis,” Dr. Cotton said.
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