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Xarelto 113 articles

Xarelto makers test drug on patients with CAD, PAD


A study investigating the effectiveness of the blood thinner Xarelto in patients with coronary artery disease (CAD) or peripheral arty disease (PAD) was halted prematurely after an interim analysis showed the medication helped prevent heart attacks, strokes and cardiovascular death. But the study has yet to reveal the rate of bleeding events, a known side effect of Xarelto. CAD and PAD are conditions in which there is a narrowing and blocking of the arteries in various critical regions of the body. CAD affects the heart’s arteries whereas PAD usually affects the arteries in the legs, but can also be used ... Read More

Newer blood thinners linked to new adverse events


Analyses of so-called real life data comparing a newer class of blood thinners with the long-used warfarin has revealed new adverse events not previously associated with the anticoagulants. Direct oral anticoagulants, such as Pradaxa, Xarelto and Eliquis, hit the market beginning in 2010 and are quickly vying for market share under warfarin. They are used to prevent strokes in patients with atrial fibrillation, to treat and prevent deep vein thrombosis and pulmonary embolism, and to prevent blood clots in people who have recently undergone hip or knee replacement surgery. The drugs are gaining popularity over warfarin because they are more ... Read More

There remains an unmet need for novel anticoagulant reversal agent


With the increasing popularity of new novel anticoagulants over the long-used warfarin for the prevention of strokes in atrial fibrillation and other blood clot-related conditions, there remains an unmet need for an antidote to reverse the blood thinning effects of the drugs in the event of a bleeding emergency. The new line of blood thinners were introduced in 2010 and include the direct thrombin inhibitor Pradaxa, and the oral factor Xa inhibitors Xarelto, Eliquis and Savaysa. All anticoagulants increase the risk of major uncontrolled bleeding and life-threatening bleeding events, including gastrointestinal bleeds, rectal bleeds, and brain bleeds. There are currently ... Read More

Xarelto linked to more GI bleeds than Pradaxa, Eliquis


A study published in the journal Gastroenterology pitting three newer blood thinners – Pradaxa, Xarelto and Eliquis – found that patients taking Xarelto were at a 20 percent greater risk of gastrointestinal bleeds compared to patients taking Pradaxa or Eliquis. The three blood thinners are in a new class of anticoagulants called Factor Xa inhibitors. They are used to prevent strokes in patients with the common heart rhythm condition called atrial fibrillation. They are also used to treat various blood clot-related conditions. Pradaxa contains the active ingredient dabigatran; Xarelto contains rivaroxaban; and Eliquis contains apixaban. The retrospective study used data ... Read More

New York, Louisiana considered for Eliquis MDL


Bristol-Myers Squibb Co. and Pfizer Inc., are asking the U.S. Judicial Panel on Multidistrict Litigation to centralize the 34 lawsuits alleging the companies’ blood thinner Eliquis caused bleeding injuries in the Southern District of New York, where both companies are headquartered. Doing so would improve efficiency and consistency, the drug companies argued. All but two of the plaintiffs suing Bristol-Myers Squibb and Pfizer support consolidation in a multidistrict litigation. Where to centralize the cases is the issue. New York leads in the number of cases with 16. The Eastern District of Louisiana is a distant second with four cases. But ... Read More

Patients suing maker of defective blood test kits


Two people have filed a proposed class action lawsuit in Massachusetts federal court alleging health diagnostics company Alere Inc. used deceptive marketing practices to lure customers into buying its inaccurate home blood test kits that yielded inaccurate results and put patients’ lives at risk. J.E. from Virginia and J.D. from Arizona filed an amended complaint in October over Alere’s INRatio system, which is used to measure blood clotting factors in patients’ blood and lets patients know whether dosages of their blood thinning medication warfarin need to be adjusted to prevent spontaneous bleeding or the formation of a blood clot. According ... Read More

Cardiovascular drugs land on FDA side effects watch list

heart chart, stethoscope

Cardiovascular drugs dominated the Food and Drug Administration’s watch list of medications with possible safety issues collected and identified by the FDA Adverse Event Reporting System (FAERS) third quarter 2016 report. The list shows potential signals of serious adverse events and safety information and that the agency says it is evaluating to determine whether regulatory action is required. The first set of cardiovascular drugs involves all blood thinners in a new class of anticoagulants called factor Xa inhibitors. Those medications include Eliquis (apixaban), Pradaxa (dabigatran etexilate mesylate), Savaysa (edoxaban tosylate), and Xarelto (rivaroxaban). Factor Xa inhibitors are used to prevent strokes ... Read More

Xarelto potentially linked to painful, incurable blood vessel condition


Some people who have been treated with a newer class of blood thinners that includes the brand names Eliquis, Pradaxa, Savaysa and Xarelto, have developed a painful and incurable inflammation of the blood vessels called vasculitis. The Food and Drug Administration (FDA) is evaluating the reports to determine if further action is necessary. The cases were identified in the quarterly (July-September 2016) Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS). The appearance of a drug on FAERS does not mean that the FDA has concluded that the drug causes the mentioned side effect. ... Read More

2016 year-end review of FDA medical device safety alerts

year calendar

The Food and Drug Administration (FDA) issued about 60 Safety Alerts involving medical devices in 2016. Here is a sampling of safety issues that the agency alerted the public about: Olympus and Pentax updated the reprocessing instructions for their specialized endoscopes, called duodenoscopes, in an effort to cut down on the risk of patient-to-patient spread of bacteria that can lead to drug-resistant infections. The devices, which are fed down patients’ throats to treat or diagnose conditions of the pancreas, have crevasses that can harbor bacteria even after the devices have been cleaned and disinfected. The FDA ordered manufacturers to provide ... Read More

Winter nose bleeds are more dangerous to people using blood thinners


Arctic cold temperatures are pouring over the country offering a hint of what lies ahead for the next few months. It is important during the freezing winter months to be mindful of your health. Cooler temperatures can impede immune systems making people more susceptible to colds and other infections. Winter can also cause nose bleeds, which for some individuals can be dangerous. The nose plays an important role in cold weather. It acts as a filter and helps to humidify and warm air before it reaches the lungs. It’s a defense mechanism that helps keep bacteria, dust and other irritants from ... Read More