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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.

Video Thumbnail
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.

Free Guide Download

The Step-By-Step Guide To Taking Action

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

Free Guide Download

The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

There are many controversial issues that political candidates build their platforms on, and public health and the environment are certainly hot topics. Congresswoman Tulsi Gabbard (D-Hawaii) is the first federal legislator and presidential candidate to call for a ban on Roundup weedkiller and we’re thrilled that she’s bringing this important topic to the forefront of political debate.

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

Financial Contributions and Political Support

It’s no secret that mega corporations give financial contributions to political candidates and officials, not to mention lobbyists. In fact, Monsanto’s website even admits:

“Monsanto is committed to participating constructively and transparently in the political process, as such participation is essential to the Company’s long-term success. Our approach on corporate political contributions is driven by the significant impact that public policy decisions can have on our business and on the interests of our stakeholders.”

Fortunately, these political contributions are open to the public to view, so here are some numbers to think about:

Paid to the House of Representatives in 2013

Total paid by Monsanto to Democrats: $72,000
Total paid by Monsanto to Republicans: $190,500

Paid to Senate in 2013

Total paid by Monsanto to Democrats: $37,500
Total  paid by Monsanto to Republicans: $85,000

Contributions to Federal Candidates, 2018 cycle

Total Contributions from this PAC to federal candidates: $315,000 (33% to Democrats, 67% to Republicans)

House: Total to Democrats: $92,500; Total to Republicans: $193,500
Senate: Total to Democrats: $23,500; Total to Republicans: $41,500

When you consider the bills and political decisions that involve adding a warning label to the products, banning glyphosate, use on city property, and more, Monsanto’s contributions are having an impact on government regulations and thereby public health and safety.  

This is precisely why it’s so refreshing to hear that Congresswoman Tulsi Gabbard is standing up against Bayer (who acquired Monsanto in 2018) by stating on Twitter, “I’ve said it before, I’ll keep saying it: Ban roundup! It’s long past time we stopped relying on corrupt corporations with a profit incentive to fund science telling us their chemicals are ‘safe.’ Victims shouldn’t have to go to trial to get the truth.”

Between the two recent California trials that found in favor of the plaintiffs who were diagnosed with cancer due to use of Roundup, new studies that found that Roundup causes a 40% increased risk of cancer, and LA County’s recent ban of Roundup on county property, hopefully more politicians will listen to researchers and their constituents and ban Roundup.

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Sources
“Presidential Candidate Says ‘Ban Roundup!’” Organic Consumers Association. Accessed April 4, 2019. https://www.organicconsumers.org/blog/presidential-candidate-says-ban-roundup#close
“Extensive List of Politicians Paid Off By Monsanto”. Natural Society. Accessed April 4, 2019. http://naturalsociety.com/list-politicians-paid-off-by-monsanto/
“Political Disclosures”. Monsanto. Accessed April 4, 2019. https://monsanto.com/company/governance/political-disclosures/
“Monsanto Co.” Open Secrets. Accessed April 5, 2019. https://www.opensecrets.org/pacs/pacgot.php?cmte=C00042069

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

As someone who’s had medical issues ranging from chronic pain to infertility, I’m no stranger to being poked, prodded, given a plethora of prescriptions, and feeling more like an alien abduction than a patient being presented solutions to feel better. Sound familiar?

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

And why do we subjugate ourselves to being guinea pigs to test which therapies, pills, and mechanical parts will torment our bodies? It’s simple. We’re desperate for help and we trust the men and women in scrubs and suits to honestly want to help us. The FDA’s fast tracked 510(k) process,  doctors receiving “gifts” from pharmaceutical companies for prescribing their products, and sky high drug prices are just a few examples of the many parts of the system that are broken at the expense of patient health. Here’s another important flaw with the FDA and Big Pharma: their lack of post-market medical device follow-up.

But why should you take the time to learn about this? Consider these statistics:

  • In 2018, medtech (medical technology) stocks climbed 26%.
  • About 1.4 million hip and knee replacement surgeries were performed in 2017 alone and the number continues to increase each year.
  • The U.S. medical device market was $147.7 billion in 2016 and is projected to grow to $173 billion in 2019.

If you don’t already have a medical device, chances are high that you’ll either have one or you know someone who has one. Plus, this is big money for pharmaceutical companies so a variety of products are probably going to be advertised or recommended to you. Don’t you want to make sure that something this important is proven to help and not harm you?

The FDA’s 510(k) Approval and Post-Market Follow-up Process

The FDA established the 510(k) process to promote medical innovation and approve needed products to market quickly. However, this once “noble” function has now turned into a manipulation of Big Pharma to speed devices to market to for profit and to bypass expensive testing. The 510(k) process allows the FDA to fast-track paperwork through the system as pharmaceutical companies base their devices on previously approved ones… all without human clinical trials.

There are many problems to this practice. First of all, the products that they’re comparing the new one to may have been ineffective or harmful and taken off the market (such as the case involving Protegen transvaginal mesh). Secondly, this is how 70 percent of medical devices are being approved; again, WITHOUT human clinical trials. Is it any wonder why there are so many health complications and recalls concerning medical devices?!? Finally, the FDA is understaffed and underfunded which makes approving, monitoring, and following up on drugs and medical devices a nightmare.

Post market follow-up is critical to patient safety, as the FDA explains that the requirements, “include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Let’s take a closer look at a recent example that hit the news in March 2019. Mentor Worldwide MemoryShape breast implants were approved in 2013. It came to the FDA’s attention that the company failed to enrol the required number of subjects in the post market study, had poor follow-up rates with patients (only 61 percent), and significant data wasn’t consistent.

These studies are particularly important because in 2016 it was determined that breast implants can cause breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Post-market surveillance could not only ensure the safety of those in the study, but it can provide valuable information to prevent future patients from suffering from this disease.

Post-market surveillance is a critical part of the FDA’s job and public health depends on it. To quickly approve high risk medical devices and neglect monitoring how they work is not only negligent, but it deliberately disregards the health of the millions of patients that the FDA and pharmaceutical companies claim to be helping. It’s time to put patient health first.

 

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Sources
“FDA warns J&J unit and Sientra over breast implant compliance”. Medical Device Network. Accessed March 25, 2019. https://www.medicaldevice-network.com/news/fda-warns-jj-sientra-breast-implants/
“Robots, DNA And Implantable Devices — Why 2019 Isn’t Your Dad’s Medtech”. Investor’s Business Daily. Accessed March 25, 2019. https://www.investors.com/news/technology/medical-equipment-medtech-2019-preview/
“Defenders: How medical devices are approved by the FDA and why some say it no longer works” KVUE. Accessed March 25, 2019. https://www.kvue.com/article/news/defenders-how-medical-devices-are-approved-by-the-fda-and-why-some-say-it-no-longer-works/269-2a9bfbe6-dd7d-4b2b-a0c1-6bebe24998cb
“Postmarket Requirements (Devices)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm
“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

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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