The reliability of the clinical trial results that allowed the FDA to approve Xarelto, a blood thinning drug, was called into question by the European Medicines Agency (EMA). However, EMA ended up supporting the drug’s safety after it concluded its investigation panel.
According to EMA a device used during the ROCKET-AF study in order to determine the INR (international normalized ratio) of patients was found to be defective. The INR is an important parameter that is used to measure the speed at which blood coagulates. The ROCKET-AF study was a clinical trial, involving 14,000 patients, for evaluating the safety and effectiveness of Xarelto. While a lot of lawsuits have been filed against the drug, EMA’s decision ended up being in favor of Xarelto’s safety.
A comparison was made between Xarelto and Warfarin to see which blood thinner was better at preventing strokes in patients suffering from atrial fibrillation (AFib). While the results allowed the FDA to approve Xarelto in 2011 the EMA came forward saying that the results were unreliable due to the use of a defective device that was recalled in 2014. A low reading due to the ineffective device could suggest that the medication dose of the patients on Warfarin was wrongly increased and thus, lead to a serious risk of bleeding. In order to see if Xarelto was safer compared to Warfarin the risk of potential fatal bleeding of both drugs had to be compared.
The Dangers of Xarelto
Thousands of patients have had their lives ruined due to the side effects of Xarelto With no antidote being available, bleeding incidents because of the drug have become fatal for a lot of patients. Nearly 3,000 lawsuits have been filed demanding compensation from the manufacturers, Bayer AG and Janssen Pharmaceutical. The cases have been consolidated in the Multidistrict Litigation MDL-2592 in Louisiana’s Eastern District. The cases are being supervised by Judge Eldon E. Fallon.
A lot of attorneys were hoping that EMA’s investigation would tip the scales in their favor. However, that was not the case as EMA Committee for Medicinal Products for Human Use (CHMP) ended up supporting Xarelto’s safety instead. EMA’s support means that the drug will continue to be used in order to prevent strokes in AFib patients.
Regardless, in the United States, Xarelto lawyers are helping people to continue to fight the manufacturers for producing a drug that has gravely affected thousands of people.