Blood thinner Xarelto drug that has allegedly caused a number of adverse side effects for patients, as a result FDA approval for the much-anticipated antidote known as AndexXa, under development by Portola Pharmaceuticals, has been delayed. The US Food and Drug Administration has postpone the approval of Portola Pharmaceuticals’ anticoagulant antidote product for uncontrolled bleeding linked to blood thinners including Xarelto (rivaroxaban) . On 17th of August the FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for AndexXa (andexanet alfa). The (CRL) states that the agency needs additional information on the drug’s manufacturing and clarify that it needed to review changes Portola made to its post-marketing commitments.
The Current Litigation and allegation
There are several lawsuits are filed against the subsidiary company of the Johnson and Johnson Corporation, Janssen Pharmaceuticals, and Bayer AG. Since lawsuit numbers continue to increase naming the same defendants with similar allegations, all federally-filed, the lawsuits will be consolidated for multidistrict litigation under the MDL 2592. Approximately 6,000 pending lawsuits are in process regarding Xarelto alleging the drug has caused uncontrollable and life-threatening internal and external bleeding. Xarelto associated with severe adverse events include internal bleeding, fatal brain and stomach bleeds. There is allegedly no antidote to stop uncontrolled bleeding, which can lead Xarelto to cause someone to bleed to death. The company stated that at present there is no reversal agent for uncontrolled bleeding linked to these drugs.
Anticoagulation is needed due to life-threatening or uncontrolled bleeding cause by the drugs. But, last year the FDA granted accelerated approval to Boehringer Ingelheim’s Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. Pharmaceutical companies are currently working on developing an antidote for the drug but one has not yet been approved. According to the plaintiffs manufacturers withheld information about the lack of an antidote along with the prescribing information and they claims that if the company had warned of the risks, then patients would have been prescribed the drug warfarin, a medication in which internal bleeding can be treated with dosages of Vitamin K.
Xarelto have received two “black box” warning
The U.S. Food and Drug Administration approved and released Xarelto to the consumer market in 2011. Xarelto benefits may have initially overshadowed the dangerous risks associated with it. However many plaintiffs have filed lawsuits against the manufacturers of the drug alleging they fail to inform users of the serious risk created by the lack of an antidote. The major side effect cause by Xarelto is, it increases the risk of fatal bleeding. Xarelto have received two ‘black box’ warnings from the FDA because of the high risk associated with the drug. These warnings are the strictest warning a product can receive before being pulled completely from the market. The first warning alerts patients that receiving spinal anesthesia (epidural) or undergoing spinal procedures (spinal tap) while taking Xarelto can cause paralysis. The second warning informs users with nonvalvular atrial fibrillation that the discontinued use of Xarelto may increase the risk of blood clots and strokes in those patients.
The Xarelto lawsuit have been centralized and are set to begin in February 2017; the federal Xarelto MDL is listed as Case No. 2592 filed against Xarelto manufacturers, Bayer and Janssen Pharmaceuticals for pretrial proceedings and bellwether trials. As per Judge Eldon E. Fallon’s alignment the first four bellwether cases have been slated for hearings. The initial two Xarelto bellwether trials will take place in the Eastern District of Louisiana, where the MDL is centralized. On February 6, 2017 the first trial will be held and the second will take place on March 13, 2017. In additionally, the third and fourth bellwether cases will be heard on April 24 and May 30, 2017, in federal district courts yet to be specified in Mississippi and Texas, subsequently. If you or your love ones are facing fatal complication due to real brad of Xarelto can take a legal action against the company. Contact Drugsclaim.com for free case review.