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Bayer 396 articles

FDA approves Xarelto, Eliquis antidote AndexXa

After nearly two years rife with rejections and requests for more information, Portola Pharmaceuticals’ AndexXa has been approved by the Food and Drug Administration (FDA), as the only antidote to reverse the blood thinning effects of the Factor Xa inhibitor anticoagulants Xarelto and Eliquis, in cases of life-threatening or uncontrolled bleeding. Xarelto and Eliquis work by inhibiting a protein involved in the formation of blood clots. They are used to prevent strokes in patients with the common heart rhythm abnormality atrial fibrillation, to prevent and treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who ... Read More

Xarelto victims ask appeals court to vacate decisions of first three trials

Plaintiffs in three bellwether trials involving bleeding risks with the blood thinner Xarelto that resulted in wins for the defendants have asked an appeals court to vacate the decisions arguing that the judge overseeing the trials improperly excluded key evidence and gave jurors incorrect instructions, The National Law Journal reported. The cases were the first three to go to trial among more than 20,000 pending in a multidistrict litigation in the Eastern District of Louisiana. Plaintiffs accuse Johnson & Johnson’s Janssen Pharmaceuticals and Bayer of not adequately warning of the risks involved with using Xarelto, including bleeding risks like gastrointestinal ... Read More

Xarelto bleeding victim fights drugmakers’ motion to throw out case

A man suing Johnson & Johnson’s Janssen Pharmaceuticals and Bayer over Xarelto bleeding risks pushed back against the drug companies after they asked the judge overseeing the case in Philadelphia to drop the case because his prescribing doctor testified he did not read Xarelto’s safety label. Daniel Russell argued that the focus should not be on that doctor – Dr. Riple Hansalia – because he was simply continuing a prescription made by another physician – Dr. Ihab Girgis – the day before. Thus, Dr. Girgis should be considered the relevant prescriber under the law, Russell argued. Furthermore, Dr. Hansalia may ... Read More

J&J profits despite mounting Xarelto lawsuits

Johnson & Johnson told investors that it expects to rake in between $81 billion and $81.8 billion in profits for 2018, more than previously forecasted, and $20 billion in first-quarter sales – up 12.6 percent year-over-year, thanks in large part to its pharmaceutical unit. But one drug that fell under the company’s expectations was its blood thinner Xarelto. Xarelto posted a sales increase of 13 percent to $578 million, but missed the company’s estimate of $634 million. Johnson & Johnson blamed supply issues caused by Hurricane Maria and changes in access agreements with insurers. Despite these challenges, Xarelto gained 1.6 ... Read More

Janssen, Bayer ask judge to toss latest Xarelto side effects trial

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer asked a Philadelphia judge to toss a case currently in trial blaming the drug companies for not adequately warning about bleeding risks with their blood thinner Xarelto, arguing that there is no evidence that the prescribing physician in the case would have given the plaintiff a different medication if stronger warnings had been on the label, because he testified he didn’t even read the drug’s label. As a result, Janssen and Bayer argued, the plaintiff doesn’t have a case. The trial involves the case of Daniel Russell, who in April 2013 had a ... Read More

FDA restricts sales of permanent birth control device Essure

Sales of the permanent birth control device Essure have been restricted by the Food and Drug Administration (FDA) for only doctors and health care facilities that agree to go over a checklist with women before the device is implanted explaining possible risks. The action comes more than a year after the FDA ordered manufacturer Bayer to update the safety label of Essure to include a black box warning about potential injuries associated with use. Essure was approved by the FDA in 2002. It consists of two nickel alloy coils that are inserted into the each of the fallopian tubes. Over ... Read More

Second Xarelto side effects trial underway in PA

Johnson & Johnson’s Janssen Pharmaceuticals and Bayer failed to warn doctors about the significantly increased risk of internal bleeding their blood thinner Xarelto posed to patients who were also taking other antiplatelet medications, attorneys for a man suing the companies said during opening arguments in the second trial in a mass tort program in Philadelphia County. In 2013, Plaintiff Daniel Russell had a stent placed to treat a blocked coronary artery. He also had an irregular heartbeat. At that time, he was prescribed two anti-platelet medications, aspirin and Plavix, to prevent blood clots. Soon after, his heart was shocked back ... Read More

Second Xarelto trial underway in Philadelphia County

The second case among more than 1,700 in a mass tort program in Philadelphia County Court of Common Pleas over claims that the blood thinner Xarelto caused seious harm to patients, is scheduled to go to trial this week. The trial involves the case of Daniel Russell, who was prescribed Xarelto in May 2013 to prevent strokes after he was hospitalized with a heart condition. Seven days into his Xarelto treatment, Russell suffered a gastrointestinal bleed. He claims his major bleeding event was caused by Xarelto because at the time he was prescribed the drug he was already taking two ... Read More

Bayer recalls mislabeled packages of Alka-Seltzer Plus

Bayer is recalling some of its Alka-Seltzer Plus medicines because the ingredients on the front sticker of the boxes may not match the actual product in the carton, which poses an allergy or anaphylactic reaction risk, a medication contraindication risk, and the potential for serious health consequences. To date, however, no injuries related to this issue have been reported. Affected Alka-Seltzer Plus products were sold in the U.S. at Walmart, CVS, Walgreens and Kroger (including Dillons Food Stores), Fred Meyer, Fry’s Food Stores, Ralphs, King Soopers and Smith’s Food and drug after Feb. 9, 2018. They can be identified by ... Read More

1,200 Xarelto cases to be prepped for trial

U.S. District Judge Eldon Fallon has ordered more than 1,200 cases alleging Johnson & Johnson’s Janssen Pharmaceuticals and Bayer’s blood thinner Xarelto caused severe injuries to be prepared for trials in courts across the country. Half of the cases were assigned for discovery by the end of April. The second wave will be selected by Aug. 30. Johnson & Johnson and its subsidiary Janssen face about 22,900 cases. Bayer faces about 22,000. All claim that the drug makers did not adequately warn doctors or patients about the risks associated with their blockbuster anticoagulant. Xarelto has been linked to bleeding events ... Read More