Public Citizen is putting pressure on the FDA to refuse approval of a new oral anticoagulant rivaroxaban (Xarelto) to be used as a preventative measure for strokes in atrial fibrillation (AF) patients.
Public Citizen sent a letter to the FDA on October 20, 2011, that said that a lot of uncertainty remains about rivaroxaban in comparison to vitamin K antagonism when it comes to preventing strokes in AF patients. In a large-scale study of the drug being used for this purpose, questions were raised as to whether the rivaroxaban is as safe and effective as warfarin. Public Citizen officials have said that the trial “had a suboptimal control arm, showed a possible rebound excess in stroke occurrence following rivaroxaban discontinuation, tested only one dose of the study drug with no rationale as to why the chosen dose was used and involved ethical concerns related to study protocol and conduct.”
Even though the FDA’s Cardiovascular and Renal Drugs Advisory Committee actually recommended the rivaroxaban for approval in September, Public Citizen is stating that the drug regulators’ own clinical reviewers said the drug shouldn’t be approved unless the makers of the drug do more studies to prove that rivaroxaban is more safe and effective than warfarin. The group also pointed out that many of the committee members had “serious reservations” (even though they voted yes) and many unanswered questions remain about the drug being used for stroke prevention that will require more studies to resolve. The Public Citizen also wants the drug to be restricted to a third-line drug.
“With so much uncertainty as to whether rivaroxaban is truly as safe and effective as existing therapy to prevent such strokes, and with two drugs already available to treat this condition, the FDA must not rush to approve rivaroxaban for such a broad use,” the letter states.
Multaq is a drug used to treat AF, as well. Studies have shown that Multaq causes liver failure and worsens the AF symptoms in some patients.
If you have been suffering from liver failure or a worsening heart condition after taking Multaq, contact attorney Greg Jones today for a free consultation. I am experienced with fighting Multaq lawsuits and I may be able to help you recover money for your injuries.