In a surprise announcement by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), Rivaroxaban is being recommended for acute coronary syndrome indication. Rivaroxaban, an anticoagulant medication used to treat AF patients, is currently approved for use in stroke prevention in AF patients.
Curiously, this decision by the EMA closely follows the FDA’s decision to refuse approval for the drug at this time. During a summarized statement that was released on March 22, 2013, CHMP announced the recommendation of Rivaroxaban’s new indication when given in dosages of 2.5 mg. The summary stated:
“Xarelto (a brand name for Rivaroxaban), coadministered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.”
The 2.5 mg dose was tested in the ATLAS ACS 2 TIMI 51 trial, which resulted in a lowered death rate in heart patients when judged against a placebo. This was in spite of the fact that the drug also increased the patients’ bleeding risk, which is why the FDA isn’t ready to approve the drug for this purpose just yet. However, the study also showed that in the higher 5 mg dose, the bleeding risks outweighed the benefits. Rivaroxaban is already being used in a 20 mg dose for stroke prevention in atrial fibrillation (AF) patients also suffering from heart failure.
AF is a condition that is characterized by patients experiencing irregular heartbeats or flutters. It is treated with various different methods including anticoagulant medications like Multaq. Multaq is made by Sanofi-Aventis and has been linked to serious side effects including a worsening of the heart condition, liver failure and lung toxicity. It is for this reason that the FDA has recommended that doctors only prescribe Multaq if all other medications fail to work.
If you or a loved one has suffered from liver failure or a worsening heart condition after being treated with Multaq, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Multaq lawsuits and may be able to help you recover money for your injuries.
About Greg Jones Law
You May Also Like