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Actemra

Actemra Linked To Potentially
Fatal Adverse Effects

“It is not the culture of U.S. medicine to report adverse events to the FDA.”

Dr. David Kessler, Former FDA Commissioner

What is Actemra?

Actemra is a prescription immunosuppressive drug used to treat adults with moderate to severe rheumatoid arthritis, giant cell arteritis, polyarticular idiopathic arthritis and systematic juvenile idiopathic arthritis. Unlike other rheumatoid arthritis drugs that are on the market, Actemra’s has been linked to over a thousand wrongful deaths and millions of ADEs (adverse drug events). Actemra’s warning label fails to inform patients of the potential life-threatening conditions that can occur from taking this medication such as heart attack, stroke, lung disease, pancreatitis, and death.

Actemra Risks and Side Effects

Over 1,000 patients have wrongfully died and tens of thousands have had adverse drug experiences with conditions associated with Actemra since it entered the U.S. marketplace in January 2010. When Actemra was approved and put in the marketplace, Roche – Genentech boasted in their marketing materials that unlike competing arthritis meds, their medication was not associated with heart attacks, heart failure or other life-threatening lung complications. However, this is not the case.

The problem with Actemra is that while this medication doesn’t create more risks than other RA drugs (in fact, the side effects are about the same), the label fails to warn patients about the risks they may encounter once they take Actemra. Much like the medication Vioxx, it was quickly approved by the FDA with only short-term clinical studies to prove that it was safe. As time progresses, more problems are being reported from patients who have used or are using Actemra.

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Everything you need to know about Actemra

Video: Everything you need to know about Actemra

Watch this video to learn the who, what, when, and where of Actemra. With any medical drug or device it is always better to know too much than be left in the dark without any information. Learn more about the damages caused by Actemra and find out what to do if you have been injured.

Video: What To Do If You Took Actemra

It’s not your fault that you weren’t told about the adverse effects from taking Actemra. We are here to help get you the information you need. Learn more now.

Video: Where Did Actemra Go Wrong?

If over 1.5 million Americans are afflicted with rheumatoid arthritis how many prescriptions could there be for Actemra? What exactly went wrong with Actemra’s labeling?

Video: Issues with Actemra

There are serious risks in taking Actemra that you should know about. For more on damages caused by Actemra and what to do if you’ve been injured, watch now.

Video: How Does Actemra Work?

Actemra can be self administered or delivered by a doctor, caregiver, or nurse. Learn how this drug functions by changing how the immune system works.

Video: The History of Actemra

Who makes Actemra and what is it used to treat? How is Actemra different from other rheumatoid arthritis drugs on the market? Find out now.

Actemra Risks and Side Effects

Roche – Genentech Fails to Warn Patients of Dangerous Potential Effects From Taking Actemra

Over 1,000 patients have wrongfully died and tens of thousands have had adverse drug experiences with conditions associated with Actemra since it entered the U.S. marketplace in January 2010. When Actemra was approved and put in the marketplace, Roche – Genentech boasted in their marketing materials that unlike competing arthritis meds, their medication was not associated with heart attacks, heart failure or other life-threatening lung complications. However, this is not the case.

The problem with Actemra is that while this medication doesn’t create more risks than other RA drugs (in fact, the side effects are about the same), the label fails to warn patients about the risks they may encounter once they take Actemra. Much like the medication Vioxx, it was quickly approved by the FDA with only short-term clinical studies to prove that it was safe. As time progresses, more problems are being reported from patients who have used or are using Actemra.

Actemra Lawsuits and Settlement Landscape

If you or a loved one took Actemra and suffered from heart failure, heart attack, stroke, pancreatitis, interstitial lung disease, gastrointestinal perforation or death, then you may be able to receive financial compensation. Investigations are underway to determine the extent of the damages incurred by innocent patients after taking this drug.

Actemra was put on the market in 2010 and since then, countless patients have suffered needlessly due to complications linked to taking Actemra. Patients (both past and present) were never warned of the potential risks and were not given the opportunity to make a fully informed decision for their situation. Roche – Genentech knows that their drug puts patients at risk, and yet they still have failed to update their warning label when every other drug in its class has.

Roche – Genentech earned $1.7 Billion in sales from Actemra in 2016.

The statute of limitations and deadlines vary by state, so it is crucial to contact Periscope Group today. We want to be certain that you get the proper representation you need if you qualify to make a claim against Roche – Genentech.

Actemra Glossary of Key Terms

Arteritis
The inflammation of the walls of arteries, usually as a result of an infection or autoimmune response. Giant cell arteritis (also called temporal arteritis) is an inflammation of the lining of your arteries. It usually affects the arteries in your head (especially those in your temples).
Arthritis
There are over 100 types of arthritis, so this term generally refers to any disorder that affects the joints.
Gastrointestinal Perforation
Many studies have shown that people suffering from rheumatoid arthritis are twice as likely to have digestive problems. High levels of inflammation and a problematic immune system likely play a significant role. A gastrointestinal perforation occurs when a hole forms all the way through the stomach, large bowel, or small intestine.
Immunosuppressive Drug
Rheumatoid arthritis is the result of the body’s immune system not working properly. It attacks the lining of joints causing inflammation and pain. Immunosuppressive drugs calm the immune system preventing severe arthritis symptoms
Interstitial Lung Disease
Rheumatoid arthritis is an autoimmune disease which doesn’t affect only your joints. This disease means that the body mistakenly attacks its own tissues and can cause scarring in the lungs which results in shortness of breath and other complications.
Pancreatitis
Your pancreas is a long, flat gland that is found behind the stomach in the upper abdomen. It produces enzymes that aid in digestion and hormones that help to regulate the way your body processes sugar (glucose). Pancreatitis occurs when the pancreas is inflamed. Complications from pancreatitis can lead to hospitalization and even death.
Tocilizumab
The generic name of the immunosuppressive drug branded as Actemra that is used to treat rheumatoid arthritis.

Health & Wellness Resources for Actemra

GET YOUR FREE ACTEMRA CASE REVIEW TODAY

You were never made fully aware of the potential life-threatening conditions that could be experienced due to taking Actemra. As claims against Roche – Genentech are mounting, Periscope Group can put you on a path to settlement. For over 20 years, we’ve served as a guardian for people who need to navigate an industry that doesn’t always have their best interests at heart. We provide the information, resources, and direct connection to reputable legal counsel that people need when their lives and livelihoods are at stake. Big pharmaceutical companies cannot silence the injured—not as long as we’re around.

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

The Link Between Medical Implants and Autoimmune Diseases

Fatigue. Brain fog. Fibromyalgia. Most people don’t associate these symptoms with having a medical device, but doctors and researchers have been finding a very strong link between the two. From patients who have breast implants to those with surgical mesh or knee replacements, countless people are struggling to battle autoimmune diseases resulting from their implants and yet have no idea why they’re feeling so sick.

The Link Between Medical Implants and Autoimmune Diseases

Types of Autoimmune Diseases

An autoimmune disease is when the body attacks and damages its own tissues. An autoimmune disease can be associated with materials used in medical implants, devices, and adjuvants (substances added to vaccines such as aluminum and mercury). Here are just a few of the common types of autoimmune diseases that have been linked to medical implants:

  • Chronic Fatigue Syndrome (CFS) – This condition can also be called systemic exertion intolerance disease (SEID) or myalgic encephalomyelitis (ME). Loss of memory or concentration, unexplained muscle or joint pain, headaches, and unrefreshing sleep are characteristics of CFS.
  • Fibromyalgia – Pain, stiffness, tenderness, and soreness in the muscles at “trigger points”.
  • Multiple sclerosis – A disabling disease of the central nervous system that disrupts the flow of information within the brain and between the brain and body.
  • Rheumatoid arthritis – An inflammatory condition that results in warm, swollen, and painful joints
  • Systemic lupus – The body’s immune system starts to attack healthy tissue and may cause  painful and swollen joints, fever, chest pain, hair loss, and more.
  • Crohn’s Disease – This inflammatory bowel disease can affect any part of the gastrointestinal tract from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea, fever, and weight loss.

Types of Medical Implant Materials

Depending on the injury or treatment needed, there are many different types of materials used.

Biologic

Biologic material is derived from living tissue, which can include intestines or skin that has been processed and disinfected for use as an implant device (for example, pig skin has been used instead of plastic mesh to reinforce hernias). The tissue is sourced from pigs, cows, sheep or humans. The most important specification for a biological material is that it’s biocompatible which means that it’s able to integrate into a host without causing an immune reaction. The pros are that they are more compatible with your body. The cons include that they can break down and degenerate.

Let’s say you had breast cancer and you wish to reconstruct your breast using your own tissue. A surgeon would take tissue from your stomach, thighs or buttocks to rebuild your breast instead of using saline or silicone which have been linked to cancers and other health conditions.

Synthetic

Obviously “synthetic” is something that doesn’t occur naturally and synthetic devices can include plastics, ceramics, porcelain, and other man-made materials. These are commonly used for dental implants, sutures, hernias, and more. Ceramics are even being used in joint replacements to “reinforce it and provide improvements to the bicompatibility, joint wear and mechanical properties,” explains researcher Ana Maria Arizmendi Morquecho. The pros are that synthetic materials can be cheaper, more readily accessible, and last longer than biologics. The cons are that they can cause autoimmune disorders in the body and many times the products aren’t fully tested before being put on the market. Transvaginal mesh (TVM) is one example that left countless women worldwide with multiple health complications that cannot be resolved. TVM is made out of a plastic called polypropylene that can erode in the body, migrate, and the sharp edges can sever tissues and organs.

Metal

Metals are commonly used in implants and titanium and metal alloys are often found in hip replacements and other similar implants. These products are many times used in combination with synthetic materials to mimic bone and tissue function. While they are long lasting, many people experience autoimmune disorders since the immune system may fight a foreign object in the body. Essure was a popular permanent birth control device that was designed to be implanted in the fallopian tubes. It was made out of 55% nickel. The problem is that 20% of women are allergic to nickel and had serious reactions due to this device.

How the Body May Respond to an Implant

Medical implants can be made from a variety of materials depending on the injury or issue it is supposed to address. However, each person can react differently to each material. Here are some recent studies linking autoimmune diseases with common medical implants:

Breast Implants

In January 2019, a study was published in Clinical Rheumatology that stated that silicone may trigger immune responses that increase the risk of developing fibromyalgia and CFS. “Researchers studied 30 female patients, 47.9 years old on average, treated between 2000 and 2017, who received silicone breast implants before being diagnosed with a rheumatological condition,” explained Fibromyalgia News Today. “Overall, six patients were diagnosed with fibromyalgia, three with chronic fatigue syndrome, and 12 with depression; the remaining patients were diagnosed with other conditions, such as Sjögren’s syndrome and rheumatoid arthritis.”

Transvaginal Mesh (TVM)

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, noticed that many of his patients were experiencing the same health problems after having vaginal mesh surgery. “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog, muscle and joint pain ‘fibromyalgia, feverish temperature, and dry eyes and dry mouth,” Tervaert said. “Of those patients, 45% developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

Essure

Essure was introduced to the market in 2002 and was supposed to be a permanent, drug free birth control device for women. This coil-like implant was placed in the fallopian tubes so that eggs cannot descend from the ovaries into the uterus to be fertilized. However, Essure is made out of 55% nickel and 20% of women are allergic to this metal. According to the FDA, “From 2002 through 2017, the most frequently-reported patient problems were pain/abdominal pain (21,215), heavier menses/menstrual irregularities (9,846), headache (7,231), fatigue (5,842), and weight fluctuations (4,970). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient-device incompatibility example, possible nickel allergy (4,481), migration of the device or device component (2,936), dislodged or dislocated device (1,356), device breakage (1,044), device operating differently than expected (947), device difficult to remove (331), device difficult to insert (317), and malposition of the device (279).”

What You Need to Know About Medical Implants

One of the biggest problems with medical implants is that patients don’t know that they’re linked to autoimmune disorders. After all, how can a hip replacement cause brain fog? However, there IS a strong connection between the two and patients need to know the symptoms to look for to determine if they’re having a negative reaction to their medical device. While the implant or device may not always be able to removed or replaced, having some answers may help you to address the symptoms more effectively.

 

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Sources
“Mesh devices may be to blame for autoimmune symptoms” Medical Plastics News. Accessed March 1, 2019. https://www.medicalplasticsnews.com/news/medical-devices/mesh-devices-may-be-to-blame-for-autoimmune-symptoms/?fbclid=IwAR2fl6djkplrWEM3YqrzkHf2_Ob0vy2mqHoViraEh71P5jXNMLoByx2SoqU
“Chronic fatigue syndrome”. Mayo Clinic. Accessed March 7, 2019. https://www.mayoclinic.org/diseases-conditions/chronic-fatigue-syndrome/symptoms-causes/syc-20360490
“Silicone Breast Implants Tied to Fibromyalgia, But More Evidence Needed, Study Says”. Fibromyalgia News Today. Accessed March 7, 2019. https://fibromyalgianewstoday.com/2019/02/13/silicone-breast-implants-fibromyalgia-more-evidence-needed/
“FDA Activities: Essure”. FDA. Accessed March 11, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm#s5
“Biological Materials Information”. Engineering 360. Accessed March 13, 2019. https://www.globalspec.com/learnmore/specialized_industrial_products/pharmaceutical_biotechnology/biotechnology/biological_materials
“Scientist look for nanostructures that allow compatibility between metal, human bone tissues”. Nanowerk. Accessed March 14, 2019. https://www.nanowerk.com/nanotechnology-news/newsid=38577.php

Do You Have an IVC Filter? Here’s What’s Happening in the News

This month IVC (interior vena cava) filters have been in the news quite a bit lately as lawsuits are settling and more claims are being filed. If you or a loved one has an IVC filter, here are the important updates that you should know about this controversial medical device.

Do You Have an IVC Filter? Here's What's Happening in the News

The Problems Linked to IVC Filters

For those who are at risk for blood clots and are unable to take blood thinners, IVC filters are placed in a large vein called the interior vena cava. The filter is made up of several metal prongs that connect at one end (almost like the frame of a closed umbrella). The hope is that the device will catch any blood clots and prevent them from traveling to the heart or lungs where it could cause extensive damage or even death.

The problem with the filter is that reports have been made to the FDA stating that the device can move causing it to puncture the interior vena cava. This device may also have prongs break off causing the pieces to migrate to other parts of the body creating excruciating pain and putting patient health at risk.

Lawsuit Finds in Favor of Patient with IVC Filter

Just last month an Indiana woman went to trial and won her case against IVC filter manufacturer Cook Medical. 53-year-old Tonya Brand of Snellville, Georgia, had an IVC filter surgery in 2009 and in 2011, a prong from her filter had migrated and pushed through the vein and the skin of her thigh. Other parts had also broken off and migrated throughout her body but are unfortunately unable to be removed. After deliberating for 11 hours, the jury decided that Brand should receive $3 million to help pay for the financial hardships that her injuries have caused.

This is a landmark verdict for patients who have had similar problems with their IVC filters; this is the first case where it was decided that this kind of device has a defective design. This is also the highest monetary compensation that has been awarded for this type of case (a Texas state court jury awarded $1.2 million against Cook Medical in a failure to warn case in 2018).

Upcoming Case to Watch

The newest and most notable lawsuit concerning IVC filter injuries was filed on February 26, 2019 in the U.S. District Court for the District of Arizona. This case is said to involve a woman from Missouri who was injured by the G2® Vena Cava Filter (“IVC Filter”) manufactured by C.R. Bard and Bard Peripheral Vascular, Inc. The crux of this case is based on the issue that C.R. Bard sold a defective medical device and failed to warn about safety risks. Currently, there are 6,300 actions pending in this case. This means that instead of taking each filed lawsuit to trial, the verdict of this case will help to determine the outcome and compensation of the thousands of similar cases brought against C.R. Bard.

Should You File a Claim?

There are now over 9,000 IVC filter lawsuits pending against IVC filter manufacturers Johnson & Johnson, Cook Medical, Cordis Corporation, Rex Medical, C.R. Bard, B. Braun and more. Clearly, hundreds of thousands of people had their lives put in jeopardy and thousands suffered from the terrifying effects of their broken filters. Profits were put before people and if you were injured, you should consider filing a claim to receive financial compensation due to high medical bills, lost wages, and other monetary hardships that you had to endure.

If you had an IVC filter placed in your body between 2005 – 2017 and had it break or migrate, call Periscope Group today at (800) 511-3838. We want to hear your story.

 

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Sources
“Indiana Jury Awards $3M in IVC Filter Lawsuit”. Legal Scoops. Accessed March 13, 2019. https://www.legalscoops.com/indiana-jury-awards-3m-in-ivc-filter-lawsuit/
“Indiana Jury Awards $3M in Cook IVC Filter Bellwether Trial”. Yahoo! Finance.  Accessed March 13, 2019. https://finance.yahoo.com/news/indiana-jury-awards-3m-cook-040408228.html

 

Study Finds 45% of Mesh Implant Patients Develop Autoimmune Disorders

Surgical mesh is often used in hernia repairs and in American women for stress urinary incontinence and pelvic organ prolapse (it’s illegal in other countries to treat gynecological issues). These medical devices have been linked to complications due to mesh erosion which can cause migration, organ perforation, bleeding, and other serious issues. A new study was recently published that also linked surgical mesh to a high rate of autoimmune disorders. If you have surgical mesh or are considering a procedure that uses a medical device implant, here is the information that you need to know.

Jan Willem Cohen Tervaert, director of the Division of Rheumatology at the University of Alberta, closely monitored his patients and came to a shocking conclusion, “In my practice, I studied 40 patients who had mesh implants and found that almost all of them had symptoms such as chronic fatigue, cognitive impairment known as ‘brain fog,’ muscle and joint pain ‘fibromyalgia,’ feverish temperature, and dry eyes and dry mouth,” stated Dr. Cohen Tervaert. “Of those patients, 45 per cent developed an autoimmune disorder such as lupus or rheumatoid arthritis. And in the patients who had allergies before the implant, they were significantly worse after.”

The Problem with Medical Device Implants

Unfortunately, complications can arise when any foreign object is inserted into the body. Similar symptoms have been frequently reported in patients who have silicone breast implants. “When a foreign body is put into the body, there is an instant activation of the immune system. It continues to fight the foreign body and eventually, over time, fatigues and becomes dysfunctional,” Dr. Cohen Tervaert explains. “Large-scale studies have shown that patients with breast implants have more symptoms of ASIA (autoimmune/auto-inflammatory syndrome induced by adjuvants) and an increased risk to develop an autoimmune disorder.

Doctors have determined that patients are genetically determined whether or not they’ll have an adverse autoimmune reaction to their medical device. Dr. Cohen Tervaert found that pre-existing allergies were present in 80% of breast implant patients which just so happened to be the same percentage of patients who had allergies in his patient group involving mesh. While it seems like an obvious answer is to have patients genetically tested for allergies before having a medical device implanted, unfortunately a test like this does not yet exist.

Many patients recovered after having the medical device removed in situations involving breast implants, but this type of surgery is more complicated with surgical mesh. Tissue and nerves can grow in and around the mesh making it virtually impossible to take out the entire device for countless patients.

Discussing your concerns with your doctor and carefully weighing the risks versus the benefits are two ways to protect your health. Also, familiarize yourself with the symptoms associated with autoimmune disorders. The sooner you call your doctor to address these issues, the better chance you have at recovery.

 

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Sources
“Surgical mesh implants may cause autoimmune disorders”. Medical Xpress. Accessed December 20, 2018. https://medicalxpress.com/news/2018-07-surgical-mesh-implants-autoimmune-disorders.html?fbclid=IwAR0cIcQsQyMQBaTwBCdv5q-kExUEkzteXXX9q9cDVby4VyOTHgcvbgF3qH8

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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