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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

Doctors urge blood testing with Xarelto, despite Bayer’s claim it’s unnecessary

Posted in Xarelto

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.”

Concluding that “Indirect comparisons indicate differences in the risk of clinically relevant bleeding events” and “Important issues such as monitoring and reversal of anticoagulation are still unresolved,” (emphasis added) this research sheds lights on missteps by Xarelto’s manufacturer.  Because there is no reversal agent for Xarelto, patients using this drug who enter the emergency room cannot undergo surgery until the drug is metabolized sufficiently, causing myriad medical issues.

So, because Bayer Pharmaceuticals, Inc. failed time and again to adequately inform patients of the need for testing and the risk for bleeding linked to Xarelto, Xarelto lawsuits are currently being filed in great number.

If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the compassion, experience, and resources necessary to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

Xarelto lawsuits cite studies indicating higher risk for bleeding than Bayer reports

Posted in Xarelto

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)

Because the Xarelto Black Box Warning provided by Bayer Pharmaceuticals, Inc. insufficiently describes the excess risk for major bleeding events, Xarelto lawsuits have been filed around the world.

If you or a loved one used Xarelto and suffered a major bleeding event, you too may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the compassion, experience, and resources necessary to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

Study shows Xarelto carries higher risk for bleeding than industry standard

Posted in Xarelto

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.

[Click here to read safety communications regarding Xarelto from the FDA]

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)

As such, the team concluded that “Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD; however, the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD.”

Due to the fact that Bayer has failed to adequately warn Xarelto users of the risk for bleeding, Xarelto lawsuits are currently being filed in great number.  If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation as well.

For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

2014 – Researchers Cite Xarelto Bleeding Risk

Posted in Xarelto

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.

Results showed that “triple therapy based on any NOAC proved to be superior to dual therapy alone, but at the same time demonstrated its equivalence with dual therapy. The results for apixaban-based triple therapy were inconclusive (not superior, not not-inferior, not equivalent and, of course, not inferior to the controls).”

The team also results for Xarelto patients specifically: “rivaroxaban-based triple therapy showed that this combination treatment was superior to dual therapy alone and failed to meet the criterion of equivalence. In the comparison between rivaroxaban-based triple therapy and ticagrelor + aspirin, the RR was 1 and its 95% CI remained within a post-hoc margin of ± 15%.”  This means that Xarelto is effective for reducing the risk of stroke.

Unfortunately, the team also found that “the increased risk of bleeding with triple regimens is well demonstrated. We therefore conclude that these triple regimens did not play any important roles in the patients experiencing an acute coronary syndrome.” (emphasis added)

Because Bayer Pharmaceuticals, Inc. has provided insufficient warning concerning this risk for bleeding on the Xarelto Black Box Warning, Xarelto lawsuits are currently being filed around the world.

If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the compassion, experience, and resources necessary to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

2014 – More Research Shows Xarelto Linked to Major Bleeding Events

Posted in Xarelto

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)

Also the team studied the risk for cancer linked to anticoagulant use: “The incidence of AE-GI cancer was similar between the NOACs (D110 [0.79%], D150 [0.61%], rivaroxaban [0.83%], and apixaban [0.69%]), but numerically higher compared with warfarin (0.37%; 0.73%; 0.57%, respectively).” (emphasis added)

Due to the fact that Bayer Pharmaceuticals, Inc has failed time and again to warn users of the increased risk for bleeding linked to Xarelto, Xarelto lawsuits are currently being filed in great number.  If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

2014 – Study shows Xarelto more dangerous than other drugs in its class

Posted in Xarelto

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.

Studying elderly patients using Xarelto, Yang made some interesting conclusions.  He writes, “Rivaroxaban was noninferior to warfarin (P<0.001) for reduction in the risk of stroke or systemic embolism in the intent-to-treat population; however, superiority was not shown. … The risk of intracranial hemorrhage was significantly lower with rivaroxaban, but the risk of gastrointestinal bleeding was significantly higher”. (emphasis added)

Due to the fact that Bayer has failed time and again to adequately warn users of this risk and does not advocate regular blood tests, Xarelto lawsuits are currently being filed in great number.  If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

2014 – Xarelto linked to higher risk for bleeding

Posted in Xarelto

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.”

Because Bayer has failed to adequately warn patients of the risk for bleeding linked to Xarelto, Xarelto lawsuits are currently being filed around the world.  If you or a loved one used Xarelto and suffered a major bleeding event, you may be entitled to significant financial compensation from the manufacturer.  For a free, no-obligation case consultation, contact our team of Xarelto lawyers at the information provided below.  We have the compassion, experience, and resources necessary to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Xarelto Lawsuit Information page is a great place to start if you have any questions about Xarelto.

2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic defects of the mandibular body and ramus, where gradual bone distraction is required,” for children less than one year old.

However, the FDA writes that “Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.” (emphasis added)

Again according to the FDA, “DePuy Synthes is recalling certain lots because the device may reverse direction and lose the desired distraction distance after surgery”, noting that “children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.”

Importantly, it is made clear that “In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.”

To-date, fifteen people have been injured due to failure of the CMF Distraction System.

Click here for more information on the 2014 CMF Distraction System recall

If you or a loved one used a CMF Distraction System and suffered injury as a result, you may be entitled to significant financial compensation through a CMF Distraction lawsuit.  For a free, no-obligation case consultation, contact our team of CMF Distraction lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

(Image: DePuy Synthes)

2014 – Benicar linked to severe gastrointestinal disease

Posted in Benicar

In May 2014, Hélène Théophile and a team of researchers published an article titled “Five cases of sprue-like enteropathy in patients treated by olmesartan,” which further demonstrated that exposure to Benicar (olmesartan) is linked to an increased risk for severe gastrointestinal disease.

Here is the abstract for that article:

“We describe five cases of sprue-like enteropathy during treatment with olmesartan, [a drug] indicated for the treatment of hypertension. Patients presented severe diarrhoea, significant weight loss or dehydration, with or without intestinal villous atrophy. Clinical signs ceased upon drug discontinuation in all cases; olmesartan was reintroduced in two cases and rechallenge was positive in both. These add to the previously reported cases that led to a label change for olmesartan in the United States. However, all cases were observed in a small gastroenterology unit, which suggests that this adverse effect may not be rare. A preliminary search for the other angiotensin II receptor antagonists in the French pharmacovigilance system found severe diarrhoea and colitis, but no case with villous atrophy. Therefore, in the presence of severe diarrhoea, olmesartan or other angiotensin II receptor antagonists should be discontinued, even if the treatment has been taken for several months or years.” (emphasis added)

Due to the fact that the manufacturer of Benicar has failed time and again to adequately inform users of these and other serious risks, a number of Benicar lawsuits are currently being filed.  If you or a loved one used Benicar and suffered gastrointestinal disease, you too may be entitled to significant financial compensation.

For a free, no-obligation case consultation, contact our team of Benicar lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Call today and see how we can help.

Benicar linked to severe gastrointestinal disease

Posted in Benicar

In January, 2013, an article by Stephanie E. Dreifuss and a team from University of Pittsburgh published an article in Case Reports in Gastrointestonal Medicine titled “Spruelike enteropathy associated with olmesartan: an unusual case of severe diarrhea.”.  There, the connection between the high blood pressure drug Benicar (olmesartan) and sprue like enteropathy was again made clear.

In their paper, the team describes the case of a “64-year-old male with a history of hypertension [who] presented with worsening diarrhea and 25-pound weight loss over the preceding three months.” (emphasis added)

Dreifuss et al. continue: “Prior screening colonoscopy was unremarkable, and the patient failed conservative management. On presentation, the patient had orthostatic hypotension associated with prerenal azotemia for which olmesartan(40mg/day) was held.”

At first, the “Initial workup for chronic diarrhea was essentially unremarkable. Then, EGD was performed with small bowel biopsy, which showed a moderate villous blunting and an intraepithelial lymphocyte infiltration.”

Thankfully, after two months, the man “achieved a complete resolution of diarrhea and regained 20-pound weight.”

However, the team concluded that “Spruelike enteropathy is a clinical entity manifested by chronic diarrhea and intestinal villous atrophy. Spruelike enteropathy associated with olmesartan as a cause of drug-induced diarrhea is rare, and it has been reported only in a case series to date. This case highlighted the importance for clinicians to maintain a high index of suspicion for olmesartan as a precipitant of spruelike enteropathy.” (emphasis added)

Due to the fact that the manufacturers of Benicar (olmesartan) have failed time and again to adequately warn users of this risk, the FDA required the warning labels be updated in 2013 and a great number of Benicar lawsuits have been filed.

If you or a loved one used Benicar and suffered sprue-like enteropathy, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Benicar lawyers at the information provided below.  We have the compassion, experience, and resources required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us