Pulmonary Embolism Support Group
By far the most common form of pulmonary embolism is a thromboembolism, which occurs when a blood clot, generally a venous thrombus, becomes dislodged from its site of formation and embolizes to the arterial blood supply of one of the lungs. Symptoms may include difficulty breathing, pain during breathing, and more rarely circulatory instability and death.
Did ya'll see this:
New blood thinner approved by FDA
Drugmaker Boehringer wins race with Pradaxa.
By Naomi Kresge and Catherine Larkin
Bloomberg News
Boehringer Ingelheim GmbH won U.S. approval to sell Pradaxa, beating drugmakers including Bayer AG and Johnson & Johnson to the market with the first rival to the half-century-old blood thinner warfarin.
The Food and Drug Administration cleared the drug for patients with an irregular heartbeat that may raise the risk of a stroke, the agency said in a statement.
Pfizer Inc., Bristol-Myers Squibb Co., Bayer and J&J were racing Boehringer, the world's biggest family-owned drugmaker, to win U.S. approval for a warfarin replacement, a market Bayer has said may reach $12 billion to $15 billion a year. Pradaxa sales may reach $4 billion a year by 2020, according to an estimate from Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd.
The approval "crystallizes what was already expected to be a high hurdle" for competitors including Bayer and J&J's drug Xarelto, Scannell wrote to investors Wednesday.
Boehringer will start selling Pradaxa in the United States within days and will market the blood thinner as reducing the risk of a stroke more than warfarin, Wa'el Hashad, vice president of cardiovascular and metabolic disease marketing, said.
"We believe Pradaxa will be a blockbuster product," Hashad said, using industry parlance for medicines with annual sales of more than $1 billion.
Doctors have relied on aspirin and warfarin, developed as a rat poison and approved as a medicine in June 1954, to ward off strokes in 2.2 million Americans with the irregular heartbeat known as atrial fibrillation. Because of fears of spontaneous bleeding, a known side effect of blood thinners, some patients aren't being treated at all, Steven Nissen, head of cardiology at the Cleveland Clinic, said at an FDA advisory panel meeting in September.
The Boehringer pill is better than warfarin, which requires regular blood tests to ensure a safe, effective dose, most of the advisory panel members said.
Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is Xarelto.
"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," said Norman Stockbridge, director of the division of cardiovascular and renal products for the FDA's Center for Drug Evaluation and Research.
Read more: http://www.philly.com/inquirer/health_science/daily/20101021_New_blood_thinner_approved_by_FDA.html#ixzz130AsOaUD
New blood thinner approved by FDA
Drugmaker Boehringer wins race with Pradaxa.
By Naomi Kresge and Catherine Larkin
Bloomberg News
Boehringer Ingelheim GmbH won U.S. approval to sell Pradaxa, beating drugmakers including Bayer AG and Johnson & Johnson to the market with the first rival to the half-century-old blood thinner warfarin.
The Food and Drug Administration cleared the drug for patients with an irregular heartbeat that may raise the risk of a stroke, the agency said in a statement.
Pfizer Inc., Bristol-Myers Squibb Co., Bayer and J&J were racing Boehringer, the world's biggest family-owned drugmaker, to win U.S. approval for a warfarin replacement, a market Bayer has said may reach $12 billion to $15 billion a year. Pradaxa sales may reach $4 billion a year by 2020, according to an estimate from Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd.
The approval "crystallizes what was already expected to be a high hurdle" for competitors including Bayer and J&J's drug Xarelto, Scannell wrote to investors Wednesday.
Boehringer will start selling Pradaxa in the United States within days and will market the blood thinner as reducing the risk of a stroke more than warfarin, Wa'el Hashad, vice president of cardiovascular and metabolic disease marketing, said.
"We believe Pradaxa will be a blockbuster product," Hashad said, using industry parlance for medicines with annual sales of more than $1 billion.
Doctors have relied on aspirin and warfarin, developed as a rat poison and approved as a medicine in June 1954, to ward off strokes in 2.2 million Americans with the irregular heartbeat known as atrial fibrillation. Because of fears of spontaneous bleeding, a known side effect of blood thinners, some patients aren't being treated at all, Steven Nissen, head of cardiology at the Cleveland Clinic, said at an FDA advisory panel meeting in September.
The Boehringer pill is better than warfarin, which requires regular blood tests to ensure a safe, effective dose, most of the advisory panel members said.
Pradaxa is already sold in Europe to prevent clots after hip and knee surgery, as is Xarelto.
"Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa," said Norman Stockbridge, director of the division of cardiovascular and renal products for the FDA's Center for Drug Evaluation and Research.
Read more: http://www.philly.com/inquirer/health_science/daily/20101021_New_blood_thinner_approved_by_FDA.html#ixzz130AsOaUD
Interesting, My biggest concern I guess is whether insurance companies won't cover warfarin ibn the future becase it requires INR testing (i.e., treatment, i.e., $$), and will only cover this new one, without the "safety net" (perceived or real) of Vit K reversal. Although I suppose the cost of the new drug will remain high for a while, as there will be no generic and they need to recoup their R&D.
As an active person (as many of us are) I take the risks of internal injuries, but also take some solace, however small, that a hi does Vit K shot might mitigate many injuries (or, amy not, depending on severity, timing, etc).
As a home tester, I find the INR testing to be no big deal,m and my diet is consistent enough to keep me in a normal range to date. I don't suffer any noticeable side effects from coumadin, frankly when I get cut I don't notice that I bleed any more than I used to. So I'd prefer the coumadin to the irreversibility of the new stuff.
Chris
The drug is being introduced carefully for specific conditions. Just as no one knew the long-term effects of Warfarin 50 years ago, no one knows the long-term or low-risk effects of the newer drugs now. Just remember Exanta and the scattered cases of liver damage a few short years ago.
http://en.wikipedia.org/wiki/Ximelagatran
There is plenty not to like about Warfarin but at $4.00 per month, known safety considerations, and the easy home testing, I too will gladly wait and not be the first kid on the block,