San Diego CA (PRWEB) December 05, 2012
Resource4thePeople is joining with respected medical institutions and major media such as The New York Times in questioning the Food and Drug Administration's approval and recent review of the anti-coagulant medication Pradaxa.
The FDA, which approved Pradaxa in 2010 as an alternative blood-thinner to the 50-year-old warfarin in part because of warfarin's dangerous side effects of internal bleeding, was forced recently to review Pradaxa's safety over the very same complaints because of hundreds of Adverse Event Reports.*
The FDA data noted that since 2010 nearly 3.7 million Pradaxa prescriptions have been filled in the United States for over 725,000 patients.
The FDA said it conducted the review because it had "received a large number of post-marketing reports of bleeding among Pradaxa users" and concluded that the internal bleeding side effects -- which can be life-threatening -- were no more significant in Pradaxa than warfarin.
However, as Resource4thePeople, The New York Times** and the Huffington Post*** point out, the FDA fails the mention that while warfarin internal bleeding incidents can be treated there is no known antidote for Pradaxa internal bleeding.
In addition, Resource4thePeople notes that medical researchers posted findings in the September, 2012 edition of The Journal for The American Medical Association questioning whether the FDA's approval process for Pradaxa may have been rushed and not identified the significance of these internal bleeding side effects.****
These dangerous side effects have spawned Pradaxa bleeding lawsuits alleging that patients have suffered side effects that have led to kidney, brain, gastrointestinal bleeding and heart attacks and deaths.
These are the common allegations that the federal court system has determined should be consolidated before a federal judge in Illinois. (MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.)
Resource4thePeople also provides referrals to attorneys who are offering free consultations for victims of Pradaxa bleeding side effects seeking compensation for medical costs, loss of wages, pain and suffering and other expenses.
There are legal time limits involved so such victims should contact Resource4thePeople as soon as possible to preserve all legal options.
The American Bar Association reports that more than 100 lawsuits have been filed in federal courts over alleged bleeding risks from Pradaxa, which the association says has been linked to more than 500 deaths in the United States.*****
The ABA article also said that "Lawyers say thousands more lawsuits are expected" and that the suits claim a failure to warn of risks and the lack of an antidote to counter the medication's effects.
The ABA reports that U.S. District Chief Judge David Herndon of the Southern District of Illinois has scheduled four bellwether trials for the multidistrict litigation beginning in August 2014.
In its article, The New York Times also questions the safety of Pradaxa and the FDA's approval process for the medication:
"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."
Resource4thePeople notes that another prominent media outlet, Forbes Magazine, noticed that the FDA did not mention that there is no antidote for the Pradaxa bleeding side effects:
"For the past year, the FDA has been investigating a large number of post-marketing reports of gastrointestinal bleeding in patients who were treated with the Pradaxa blood thinner, which was approved two years ago and is marketed by Boehringer-Ingelheim). Now, the agency has concluded that the bleeding rates are no higher than among patients given warfarin, a decades-old medical standard.
The assessment was designed to allay concerns about the blood thinner, which is used to reduce the risk of stroke and blood clots in patients with atrial fibrillation, but has been linked to more than 500 deaths and more side effect reports than any other drug, according to the Institute for Safe Medicine Practices), even while generating more than $1 billion in sales.
Even so, questions remain since there is no antidote to reverse the blood-thinning effects and the FDA report did not address this contentious issue."******
The Huffington Post posted an article calling the FDA's approval process "rushed":"***
"In less than a year, Pradaxa became a blockbuster drug for its manufacturer Boehringer Ingelheim by capturing 28 percent of the market. Regrettably, the rushed approval process has resulted in too many stories with tragic endings.
According to the Philadelphia Inquirer, Pradaxa has been associated with 3,781 reported adverse reactions, including 542 deaths and 2,367 hemorrhages. Particularly at risk are elderly patients in their 80s who report the greatest number of controllable bleeds. And unlike Coumodin, there is no antidote to a patient from bleeding out."
To summarize, Resource4thePeople is joining critics of the FDA's approval process of Pradaxa and awaits the outcome of numerous lawsuits in which allegations against the drug's manufacturer will have to be proven in trials that are scheduled to begin next year.
And, as The New York Times reported in its article:
"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."