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Dangerous Drugs & Medical Devices

News & Commentary on Prescription Drug & Medical Device Lawsuits

IVC Filters: 86% Exhibit Serious Side Effects

Posted in IVC Filters

In 2012, a team of researchers from the Department of Radiology and Biomedical Imaging at the University of California, San Francisco published an article that illustrated some serious risks associated with the use of IVC filters.

Inferior vena cava filters are small metal filters inserted into the inferior vena cava vein, used in patients with deep vein thrombosis (DVT) to mechanically catch blood clots before they can reach the lungs and cause in pulmonary embolism.  Sometimes, these filters are implanted permanently, and sometimes IVC filters are implanted for a limited time, ranging from a few months to a year.

Unfortunately, IVC filters can prove difficult to remove, and research has shown that the longer an IVC filter stays in the inferior vena cava, the more likely it is to fail or cause dangerous side effects.  IVC side effects can include perforation (tearing) of the IVC vein or internal organ, IVC fracture and embolization (wherein the IVC filter breaks and travels through the blood to the heart or lungs, resulting in myriad – potentially deadly – health problems), and both tilting and migration of the device.

The team from UC San Francisco, led by JC Durack, studied 50 IVC filter patients with abdominal CT scans, and presented results of their study titled “Perforation of the IVC: rule rather than exception after longer indwelling times for the Günther Tulip and Celect retrievable filters.” in Cardiovascular and Interventional Radiology.

Durack et al. (2012) found “Perforation of at least one filter component through the IVC was observed in 43 of 50 (86%) filters on CT scans obtained between 1 and 880 days after filter placement.”

“All filters imaged after 71 days showed some degree of vena caval perforation, often as a progressive process. Filter tilt was seen in 20 of 50 (40%) filters, and all tilted filters also demonstrated vena caval perforation.”

As such, researchers concluded that “Longer indwelling times usually result in vena caval perforation by retrievable Günther Tulip and Celect IVC filters” and noted that side effects “from IVC filter components breaching the vena cava can be significant.”

Because of the high rate of IVC complications, the team suggests “filter retrieval as early as clinically indicated and increased attention to the appearance of IVC filters on all follow-up imaging studies.”

Due to the fact that many IVC filter manufacturers have failed time and again to adequately warn users of these risks, many IVC lawsuits are currently being filed, including one multidistrict litigation.

If you or a loved one used an IVC filter and suffered an adverse outcome, you may be entitled to significant financial compensation.  For a free, no-obligation IVC case consultation, contact our team of IVC lawyers at the information provided below.

We have the compassion, experience, and resources to win the compensation you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

If you have any questions about IVC filter lawsuits, see our IVC Filter Lawsuit Information page or give us a call.

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.”

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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)
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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)

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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.
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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)
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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.

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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.”

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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 – Birth defects risk increased 250% with Depacon / Depakene / Depakote

Posted in Depacon / Depakene / Depakote

In recent years, dozens of studies have been published illustrating an increased risk for birth defects linked to antiepileptic drugs containing sodium valproate such as Depacon, Depakene, and Depakote.  While these drugs are effective in the mitigation of seizures, the risks posed to developing babies cannot go overlooked.  Here, I will summarize one such study by G. Veiby et al., first appearing in the March, 2014 edition of Journal of Neurology.  This study was titled “Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy.” and comes from University of Bergen (Bergen, Norway).

The team writes, “Deliveries recorded in the compulsory Medical Birth Registry of Norway 1999-2011 formed the study population.”  In all, “2,600 children exposed to antiepileptic drugs during pregnancy were compared to all 771,412 unexposed children born to women without epilepsy.”

Among other things, results showed that “Valproate monotherapy was associated with a significant risk of birth defects (6.3 vs. 2.9 %; OR 2.5; CI 1.6-3.8), and specifically with septal heart defects and hypospadias.”  This means that children exposed to valproate in utero were 2.5 times as likely to be born with birth defects, specifically heart defects.

The team also found that if a mother who used valproate in pregnancy bore a child with a birth defect, the likelihood that she would bear another with a defect was 10.4 times higher than if she had not used the drug.

Because the manufacturers of these drugs have failed time and again to warn women of these risks, Depacon birth defect lawsuits are currently being filed around the world.

If you or a loved one used Depacon, Depakote, or Depakene during pregnancy and your child was born with a congenital malformation or had perinatal complications, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Depacon birth defect 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 – 5528

justinian@dangerousdrugs.us

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