Articles Posted in Xarelto

Xarelto, a blood thinner linked to irreversible hemorrhaging and other serious medical problems, is now under investigation for problems that may have occurred during the FDA’s initial testing of the drug. The FDA is investigating whether a device used during clinical tests may have negatively affected test results by understating the bleeding risk of patients. Contact a Boston Defective Medical Equipment Lawyer Today.

Xarelto quickly grew in popularity following its approval by the FDA in 2011. The anticoagulant, which is billed as a low-maintenance alternative to warfarin, is prescribed to patients at risk of blood clots and stroke. Up until recently, warfarin was the only option for patients suffering from these types of conditions. Warfarin requires frequent blood monitoring, an inconvenience that Xarelto patients don’t have to endure. Both warfarin and Xarelto have a risk of excessive bleeding, but there’s one major difference between the two. Warfarin-related bleeding problems have an antidote; a dose of fresh blood plasma and vitamin K, administered by a physician. Unfortunately, no antidote exists for patients who experience hemorrhaging while undergoing Xarelto treatment. This oversight has resulted in thousands of injuries and deaths.

Was there Evidence that the Device was Malfunctioning During Clinical Trials?

Until recently, the FDA’s spotlight was on the drug itself. However, new evidence indicates that a malfunctioning device during clinical trials may be to blame for the injuries and deaths. According to a recent article in the New York Times, the FDA has recently begun asking Xarelto’s manufacturer, Johnson & Johnson (Janssen), “…detailed questions about whether there was evidence that the device was malfunctioning while the trial was underway, according to a legal brief filed in federal court on Monday by lawyers for patients and their families who say they were injured by the drug. The lawyers also cited internal company documents that they said showed doctors were complaining to the trial leadership during the course of the study.”

The article also reported that, “Regulators are looking at whether the malfunctioning device might have led doctors to give patients the wrong dose of warfarin, which could have led to additional bleeding episodes and given an unfair advantage to Xarelto.” It was indicated that Johnson & Johnson (Janssen) and Bayer reportedly, “…notified regulators that the device that was used in the trial had been recalled in 2014 because it was understating patients’ risk of bleeding.” Continue reading

Up until recently, people at risk of stroke and blood clotting only had one highly-effective treatment option, warfarin. This decades-old anticoagulant (blood thinner), also known by its brand name Coumadin, has been used by millions of patients since it was introduced to the market in 1954. Although effective, warfarin is relatively high-maintenance, requiring that patients undergo routine monitoring and testing. In 2012, a new group of oral anticoagulants entered the market. Known as thrombin inhibitors, drugs including Xarelto and Pradaxa are marketed as a lower-maintenance, more convenient alternative to warfarin. The drugs’ manufacturers claim that monitoring and testing are not necessary while taking thrombin inhibitors. Unfortunately, this convenience has come with a price. Contact a Boston Drug Injury Lawyer Today.

Patients taking Xarelto are at an increased risk of dangerous hemorrhaging. 

Warfarin has similar risks, but with one major difference – an antidote. If a patient on warfarin develops uncontrollable bleeding, the physician can administer a dose of vitamin K and fresh blood plasma to halt the bleeding. No such antidote exists for Xarelto. Therefore, uncontrollable bleeding in a Xarelto patient can lead to serious health complications, and even death.

Xarelto Lawsuits Consolidated into Multi-District Litigation in Louisiana

Due to the high volume of lawsuits against Xarelto manufacturer, Bayer, Xarelto cases have been consolidated into a multi-district litigation (MDL) lawsuit in the Eastern District of Louisiana. Many of the claimants allege that after using Xarelto they developed uncontrollable bleeding, resulting in emergency health situations and, in some cases, death. Now that the lawsuits have been consolidated into an MDL, a settlement negotiation process will begin. As the bellwether trial, the outcome of this MDL is likely to set the tone for future Xarelto litigation. In addition to the failure of Bayer to adequately warn physicians and consumers about the risks associated with its drug, the FDA claims that the manufacturer also made misleading claims about the associated risks. Last May, the manufacturer of Pradaxa, a similar thrombin inhibitor, agreed to settle about 4,000 lawsuits for a total of $650 million. This is good news for claimants in Xarelto lawsuits.

Common Xarelto Side Effects That May Indicate More Serious Complications

If you develop any of the following side effects or symptoms, contact your health care provider immediately:

• Blood in urine or stool
• Coughing or vomiting up blood
• ‘Pins and needles’ feeling anywhere on the body
• Bleeding gums
• Severe back pain
• Trouble swallowing
• Difficulty breathing
• Dizziness or faintness
• Severe headache
• Chronic nosebleeds
• Numbness
• Weakness in legs

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In the wake of almost countless lawsuits against prescription drug manufacturers, physician groups are advocating a ban on direct-to-consumer advertising. This aggressive form of mass marketing encourages patients to request certain prescription drugs, medical devices, and treatments that they may not otherwise seek out. The American Medical Association (AMA) is concerned that this results in unnecessary prescribing and increases potential risks to patients. Earlier this week, the AMA voted to end aggressive marketing campaigns that do not serve to educate physicians or patients, but rather to encourage patients to ask their doctors about specific medications or products. Contact a Boston Drug Injury Lawyer Today.

In addition to protecting the health and safety of patients, banning direct-to-consumer advertising would likely also result in a significant decline in health care costs. In a press release following the vote, AMA Board Chair-elect, Dr. Patrice A. Harris, said, “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotion, and the role that marketing costs play in fueling escalating drug prices.Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” Approximately $4.5 billion is spent annually on direct-to-consumer advertising, according to the AMA. This is a 30% increase from the previous two years. Interestingly, only the United States and New Zealand allow these types of ads.

Drug Prices Have Spiked 4.7% in the Last Year

The AMA would like to see the creation of a physician task force and an accompanying advocacy campaign that encourages drug pricing transparency. In addition, they wish to see more drug options and an increase in competition among pharmaceutical companies. This year alone, drug prices have escalated by 4.7%. This increase negatively impacts the ability of patients to afford effective drugs, medical products, and treatments. Direct-to-consumer marketing also results in the widespread use of drugs that are sometimes not as effective as another option, and may be altogether unsafe. In fact, a 2014 BBC report revealed that most major pharmaceutical companies spend significantly more on marketing than they do on research. Continue reading

Xarelto, otherwise known as rivaroxaban, is a prescribed blood thinner manufactured by Bayer and marketed by Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson. Xarelto was approved by the Food and Drug Administration (FDA) in 2011 for treatment of deep vein thrombosis as well as pulmonary embolism. There is a mounting sum of evidence that claims, however, that Xarelto was not generally approved as a blood thinner. The approval for Xarelto was revised in 2012 to cover patients with reoccurring blood clots—but the decision came against the approval of the FDA’s own panel.

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Johnson & Johnson (JNJ) and Bayer AG (BAYN) are combatting efforts to consolidate Xarelto injury lawsuits filed by plaintiffs who claim that the blood thinner caused patients to suffer fatal bleeds. Bayer makes the medication, and J & J owns the rights to the drug in the United States.

Some 65 fatalities are being blamed on the drug, which does not have an antidote. Some patients say that they began to bleed internally and so profusely that they ended up going to the hospital.

The plaintiffs contend that the defendants played down the risks involved with taking Xarelto. They are accusing the companies of neglecting to tell the public about these health risks while continuing to sell the drug. J & J, however, maintains that all anticoagulants place patients at risk of bleeding and patients are made aware that this could be a potential side effect.

Plaintiffs are starting to file claims seeking dangerous drug damages for injuries they sustained from using Xarelto, a blood thinner. Bayer and Johnson & Johnson/Janssen Pharmaceuticals, which jointly market the drug, are the defendants. According to the Xarelto injury lawsuits, users are experiencing internal bleeding so severe that they have been hospitalized. They believe that the companies are continuing to sell the drugs despite the health risks, of which they are neglecting to notify the public.

Xarelto, unlike blood thinner warfarin (brand names Coumadin, Marevan, Jantoven, and Uniwarfin), does not have an antidote to stop uncontrollable bleeding. This means that excessive bleeding may lead to serious, life-threatening complications.

Xarelto is used as an alternative to warfarin. It is prescribed to prevent deep vein thrombosis after surgeries-joint replacement procedures, in particular-as well as pulmonary embolism and stroke in patients with atrial fibrillation.