In an unpublished opinion file on April 9, the Court of Appeals for the 5th Circuit affirmed a previous decision in one of the Reglan generics cases, Whitener v. Pliva, Inc. This ruling upholds the district court’s grant of summary judgment in favor of the defendant drug companies on the grounds that the defendants
On Tuesday March 3rd, the United States Food and Drug Administration required that manufacturers of testosterone supplements (or, Low-T drugs) include warnings on packaging for the increased risk for heart attack and stroke linked to these drugs.
In years past, a great many peer-reviewed scientific studies had demonstrated that men using Low-T drugs were at…
Last week, the pharmaceutical company, Takeda, was ordered to pay $1.3 million in punitive damages to a former Philadelphia schoolteacher who “argued the drugmaker’s Actos diabetes medicine caused his bladder cancer”, Japan Times writes.
Only a few days earlier, that man was awarded over $2.3 million in compensatory damages.
According to that Japan Times…
In recent years, a new anticoagulant drug called Xarelto (rivaroxaban) has been found by the FDA to increase the risk for major bleeding events over other drugs in its class. And unlike other drugs in its class, the manufacturer does not recommend regular blood testing, a simple procedure which can lower the risk for major bleeding events by 40%. Here, we discuss one piece of research titled “New oral anticoagulants in the treatment of acute venous thromboembolism – a systematic review with indirect comparisons.” on risks associated with Xarelto by an Austrian research team, published in VASA (2014).
The team studied over 27,000 patients using a variety of anticoagulants and measured the risk for stroke and bleeding events, finding that “Regarding occurrence of the composite bleeding endpoint, apixaban performed better than all other NOACs and dabigatran better than rivaroxaban and edoxaban.”
Titled “The potential role of anticoagulant therapy for the secondary prevention of ischemic events post-acute coronary syndrome”, a piece by A.C. Camuglia et al. (published in Current Medical Research and Opinion – August, 2014) from Royal Brisbane and Women’s Hospital and the University of Queensland (Queensland , Australia) reviews the safety of an anticoagulant drug called Xarelto. Recently, a number of studies have indicated that this blood thinner carries a higher risk for major bleeding events than others in its class.
The team writes, “The use of dual antiplatelet therapy has led to a substantial reduction in ischemic events post-acute coronary syndrome (ACS). Despite this, recurrent event rates remain high. Recent research has combined antiplatelet with anticoagulant therapy to reduce recurrent event rates further”, noting that while “Compared with standard medical therapy, rivaroxaban demonstrated improved efficacy outcomes and significantly reduced mortality after an ACS. Although clear benefits of novel oral anticoagulants post-ACS have been proven, concerns regarding bleeding are still a barrier to widespread use.” (emphasis added)
Continue Reading Xarelto lawsuits cite studies indicating higher risk for bleeding than Bayer reports
Here, we discuss a study titled “Clinical characteristics and outcomes with rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation but underlying native mitral and aortic valve disease participating in the ROCKET AF trial.”, published in European Heart Journal this year by G. Breithardt and a team of German researchers. This study aimed to further evaluate the safety of Xarelto (rivaroxaban), an anticoagulant drug linked to increased risk for major bleeding events.
The team writes, “Among 14 171 patients, 2003 (14.1%) had [significant vascular disease (SVD)]; they were older and had more comorbidities than patients without SVD,” and “The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD [2.01 vs. 2.43%; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.55-1.27] and without SVD (1.96 vs. 2.22%; HR 0.89, 95% CI 0.75-1.07; interaction P = 0.76).”
However, Breithardt et al. (2014) also found that “rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD (19.8% rivaroxaban vs. 16.8% warfarin; HR 1.25, 95% CI 1.05-1.49) vs. those without (14.2% rivaroxaban vs. 14.1% warfarin; HR 1.01, 95% CI 0.94-1.10; interaction P = 0.034), even when controlling for risk factors and potential confounders.” (emphasis added)
In recent years, a number of studies have shown that the anticoagulant drug Xarelto (rivaroxaban) is linked to increased risk for major bleeding events. Here, we discuss one such study, titled, “Anticoagulant-related gastrointestinal bleeding-could this facilitate early detection of benign or malignant gastrointestinal lesions?” and published in the August, 2014 edition of Annals of Medicine by A. Clemens et al.
This team states “The higher incidence of gastrointestinal (GI) bleeding with the non-vitamin K oral anticoagulants (NOACs) may be related to pre-existing malignancies; diagnostic measures triggered by these bleedings could lead to early detection of these malignancies.”
For this study, the team “retrieved the preferred terms on GI bleeding and GI cancer reported as adverse events (AEs) from phase III studies in patients with atrial fibrillation for each NOAC on ClinicalTrials.gov” and “analyzed the RE-LY trial database.”
Results showed that the risk for bleeding was different with different drugs: “dabigatran 110 mg b.i.d. (D110: 1.42% versus 1.37%), dabigatran 150 mg b.i.d. (D150: 1.93% versus 1.37%), rivaroxaban (3.52% versus 2.68%), and apixaban (1.93% versus 1.59%), compared with warfarin, respectively.” (emphasis added)
Continue Reading 2014 – More Research Shows Xarelto Linked to Major Bleeding Events
Recently, studies have shown that the anticoagulant drug Xarelto (rivaroxaban) is linked to a dramatically increased risk for major bleeding events compared to other drugs in its class. Here, we discuss one such piece of research, titled “New oral anticoagulants in acute coronary syndrome: is there any advantage over existing treatments?”, published in the September, 2014 edition of International Cardiovascular Research Journal by a team of Italian researchers led by A. Messori.
This team states that their study “re-examined the studies published thus far on this topic to evaluate the effectiveness of dual antiplatelet therapy in comparison to some of these new approaches (mainly, ticagrelor + aspirin and dual therapy plus a new oral anticoagulant [NOAC]; i.e., “triple therapy”).” To perform this study, the team evaluated and analyzed a number of previously-conducted studies with statistics to get a better overall picture of this risks and benefits of anticoagulant use.
Continue Reading 2014 – Researchers Cite Xarelto Bleeding Risk
Recently, the anticoagulant drug Xarelto (rivaroxaban) (Bayer Pharmaceuticals, Inc.) has been linked to an increased risk for major bleeding events, prompting a number of Xarelto lawsuits. In August 2014, medical researcher Eugene Yang published a piece in Vascular Health and Risk Management titled “A clinician’s perspective: novel oral anticoagulants to reduce the risk of stroke in nonvalvular atrial fibrillation – full speed ahead or proceed with caution?”, exploring the safety of several anticoagulant drugs. Here, we will discuss that research.
Yang states, “The aim of this review is to examine this indication from a clinician’s perspective, highlighting efficacy and safety results from the major trials with these novel oral agents. Clinical issues regarding bleeding, monitoring, and reversal are discussed, along with requirements to consider when interrupting treatment with a novel oral anticoagulant for the purpose of transitioning to another anticoagulant and prior to cardioversion, ablation, percutaneous coronary intervention, or emergency surgery.”
First, Yang found that patients using Xarelto only spend an average of 55% of time within the proper therapeutic window, the lowest of all anticoagulants reviewed. Many doctors believe that if a patient spends less than 60% of the time in that therapeutic window, more harm than good is done. It is vital to stay in that window, for too little drug places a patient at risk for stroke, and too much places a patient at risk for internal bleeding, which can be fatal.
In the United States alone, about four million prescriptions for anticoagulant drugs are filled each year. With the use of each of these drugs comes the risk for internal bleeding, but not all drugs are created equal. One such drug is Xarelto (rivaroxaban), and currently, the Xarelto Black Box Warning fails to adequately inform users of the increased risk for major bleeding events, higher than the risk linked to similar drugs, Xarelto lawsuits are being filed against Bayer Pharmaceuticals, Inc., Xarelto’s manufacturer.
In September 2014, the Journal of Cardiology published an article titled “Clinical usefulness of measuring prothrombin time and soluble fibrin levels in Japanese patients with atrial fibrillation receiving rivaroxaban.”, reviewing the safety of Xarelto.
The Japanese study team that wrote the article states, “Rivaroxaban is currently used to prevent stroke in patients with atrial fibrillation” and warns “Measuring coagulation function may help clinicians to understand the effects of this drug and the associated risk of bleeding.”
To review Xarelto, the team administered Xarelto to “136 patients with non-valvular atrial fibrillation” with an average age of 75. Results showed that “In Japanese patients with non-valvular atrial fibrillation receiving rivaroxaban, a prolonged peak PT (≥20s) could indicate increased risk of bleeding, and both trough and peak SF levels were reduced relative to baseline.”