FDA clears Xarelto blood thinner despite faulty trial device
Studies suggest that those people on these NOAC meds.. that develop uncontrolled bleeding.. that abt 12% will BLEED OUT… as in DIE !! Because only one has an REVERSAL MEDICATION.. and that can take up to TWELVE HOURS for it to stop the hemorrhaging… and if that hemorrhaging is in the brain… A STROKE … significant chance the pt will experience BRAIN DAMAGE
The U.S. Food and Drug Administration on Tuesday said it has determined the widely-used blood thinner Xarelto to be safe and effective for patients with the heart condition atrial fibrillation after serious doubts arose over the major study used to gain approval of the drug.
Xarelto, known chemically as rivaroxaban, won U.S. approval in 2011 after it was shown to be a safe and effective alternative to decades old warfarin for preventing strokes in a study of more that 14,000 patients with the irregular heartbeat condition. Without treatment, atrial fibrillation leaves patients five times more vulnerable to strokes.
In the study dubbed Rocket-AF, warfarin therapy was monitored using the Alere Inc INRatio device that has since been recalled over its potential to generate inaccurate results, casting a shadow over the value of the large, pivotal clinical trial.
“The FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the Rocket-AF study results,” the agency said in a statement posted on its website. “The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal.”
Xarelto, a multibillion-dollar product, is sold by Bayer AG overseas and by Johnson & Johnson in the United States. It is the market leader in a popular new class of medicines designed to replace problematic warfarin, which requires a special diet and regular monitoring to make sure dosing remains within a limited therapeutic range to keep it from becoming either too low, which increases stroke risk, or too high, which greatly raises the risk of serious bleeding.Warfarin, a widely used and inexpensive generic medicine, is also sold by Bristol-Myers Squibb under the brand name Coumadin. Bristol-Myers and Pfizer also sell the Xarelto rival Eliquis.
Filed under: General Problems
They are killing people. They don’t have any laws to live by. Evil people and we the people pay them to do whatever they want.
I think it is very interesting that the DEA is trying to make Kratom a scheduled 1 drug when there is currently a human drug trial that that is testing a drug that uses some of the same properties as Kratom. While the DEA say Kratom is not safe the number say otherwise. While there is a concern that Kratom is not regulated so there is a chance you may be buying something that does not even contain Kratom in it. If that is a big concern then maybe the answer would be to make the tea and pills as over the counter drugs since it is probably safer then aspirin or Motrin or Bendryl. But of course there would not be as much money for the makers if they did that.