If you or a loved one have rheumatoid arthritis, you may have been prescribed or heard of Actemra. Rheumatoid arthritis (RA) is an autoimmune disorder that causes the joints to swell and become painful. Actemra, also known as tocilizumab, is a prescription drug that is injected weekly or infused monthly to aid patients with their symptoms and slow the progression of RA.

Recently, Actemra has also been prescribed to “help” those with giant cell arteritis. Giant cell arteritis (GCA) is a blood vessel disease that causes the vessels, primarily those in the scalp and head, to swell and become inflamed.

Actemra is believed to work by blocking the protein that causes inflammation. However, the prescription medication is doing a lot more than blocking the protein that plays a part in RA and GCA: it is causing serious side effects.

Drug maker Genentech lists side effects as serious infections, stomach tears, changes in blood test results, increased risk of cancer, Hepatitis B infection, serious allergic reactions, nervous system problems, upper respiratory tract infections, headache, increased blood pressure, and injection site reactions.

All these side effects, and others that Genentech does not disclose, have generated over 13,500 adverse event reports regarding Actemra – this means that there have been over 13,500 occurrences of negative side effects reported to the FDA. Worse, over 1,100 people have died while taking Actemra.

While these numbers and these side effects are scary, they are not new. Before Actemra was released to the general public in 2010, five clinical trials were performed. During these clinical trials, over 70% of patients experienced negative side effects. Nine of these patients actually died during the clinical testing; other negative side effects were stroke, pancreatitis, lung disease, stomach tears, and heart attack.

So, if this drug is potentially bad for you, why is it still on the market? Unfortunately, Actemra received FDA-approval and Genentech was allowed to list only a few of its side effects on the prescription label, in exchange for continuing to test for negative side effects, specifically cardiac issues in patients. Additionally, the studies that reported the adverse events and the death toll are not able to definitively say whether Actemra was the actual or sole cause of death. By limiting what information it shares with patients and doctors, Genentech markets the drug as help for those with RA, GCA, and other arthritic issues, not as the potential harm it may be to patients.

People with rheumatoid arthritis are not receiving all the information they deserve. The maker of Actemra is telling us what it wants patients to hear and withholding important, potentially life-threatening information from the public. By not knowing what all the side effects of Actemra may be, patients are at risk to experience these undisclosed side effects such as stroke, pancreatitis, lung disease, stomach tears, and heart attack.

Not knowing all the potential risks and side effects associated with any prescription drug can be dangerous. Before taking any prescription medicine, including Actemra, be sure to talk to your doctor. If you or a loved one have already been harmed by Actemra, talk to me.

This post was produced through review of online new sources, clinical trial studies, and the FDA website.

If you have a specific type of leukemia—Philadelphia chromosome-positive chronic myeloid leukemia, or Ph+ CML—you may have been prescribed the chemotherapy drug Tasigna (nilotinib). Tasigna offers promise for some patients and may even be associated with remission of their disease—but it’s not without risks.

What’s more alarming, the drug’s manufacturer, Novartis Pharmaceuticals Corporation, may have known about those risks and failed to disclose them to you. People who have been harmed or lost loved ones due to Tasigna have sued Novartis. Here’s what you need to know.

What Is Tasigna?

Tasigna is a form of chemotherapy used to treat one specific genetically linked type of leukemia. In Ph+ CML, the bone marrow overproduces white blood cells. These extra white blood cells are abnormal and can overwhelm healthy cells, causing symptoms such as fatigue and anemia and eventually organ failure and premature death.

Tasigna is associated with a range of both “common” and “severe” side effects. On its website, Novartis warns that those side effects include, but aren’t limited to, the following:

• nausea;
• rash;
• headache;
• tiredness;
• itching;
• vomiting;
• diarrhea;
• cough;
• constipation;
• muscle and joint pain;
• runny or stuffy nose, sneezing, and sore throat;
• fever;
• night sweats;
• low blood count causing unexplained bleeding or weakness;
• liver damage;
• tumor lysis syndrome (TLS);
• QT prolongation, a heart problem that causes an irregular heartbeat;
• pancreas inflammation (pancreatitis);
• bleeding in the brain, which may cause confusion or loss of consciousness;
• fluid retention; and
• decreased blood flow to the leg, heart, or brain.

As if that were not enough, there’s another problem with Tasigna that Novartis isn’t talking about.

Tasigna and Atherosclerosis

Scientific studies have shown that Tasigna is also associated with atherosclerosis, where fatty deposits build up in arteries. These deposits narrow the blood vessels, eventually slowing and even stopping the flow of blood throughout the body. Because blood distributes oxygen to cells, a reduction in blood flow can lead to cells literally suffocating. Depending on what area of the body is deprived of blood and oxygen, atherosclerosis can cause heart problems and stroke and can lead to amputation of limbs. (Note that atherosclerosis is a specific type of arteriosclerosis, or hardening of the arteries. These terms are often used interchangeably, so don’t be confused if you see discussions of Tasigna causing arteriosclerosis.)

As early as 2013, Canada issued a governmental warning about Tasigna, indicating that its use was associated with “the possible risk of developing atherosclerosis-related conditions.” Canada published its warning after finding that Novartis’s own global safety database revealed 277 cases of atherosclerosis between 2005 and 2013.

But Novartis has not included atherosclerosis as a risk in the information it distributes about Tasigna in the United States. Now, some patients and their families are taking Novartis to court over it.

Tasigna Lawsuits

Dainis Lauris was prescribed Tasigna for leukemia, but he soon developed peripheral artery disease. His doctor read that the drug was linked to atherosclerosis, causing problems just like Lauris’s, and quickly changed him to a different medication. But the damage was done: Lauris died from atherosclerosis complications about six months later. He was 49 years old. Now, his family has filed a lawsuit in California federal court. They allege that Novartis knew about the drug’s risks and intentionally failed to warn American consumers or their doctors. So far, the court has denied Novartis’s motion to dismiss the lawsuit and its motion for summary judgment. The case is awaiting trial.

Have you or a loved one developed atherosclerosis after taking Tasigna? Call me for more information and to discuss your options: (919) 830-5602.

Note: This post was written from news reports and court filings. The allegations against Novartis have not yet been proven. I will provide updates as they occur. Photos are for illustrative purposes only.

Diabetes is a serious condition that affects the way the body metabolizes sugar. Over 29 million Americans currently suffer from the disease. Of the newly diagnosed cases of diabetes in adults, around 95% are for Type 2 diabetes. Type 2 diabetes occurs when the body produces enough insulin but cannot use insulin properly. Type 2 diabetes results in high blood sugar levels which can cause long-term health problems. So what does all this mean? From the perspective of pharmaceutical companies, it means there is a massive market for Type 2 diabetes drugs. Enter the latest diabetes “wonder drug,” Invokana. more Invokana

Invokana is the trade name for the medication canagliflozin. Canagliflozin is a diabetes medication sold by Janssen Pharmaceuticals and Johnson & Johnson. Invokana works to lower the body’s blood sugar levels by preventing the kidneys from reabsorbing blood glucose. The blood glucose is removed with the body’s urine. Unfortunately, many patients who took Invokana suffered side effects they did not anticipate because Janssen allegedly did not warn users adequately of these side effects. Injuries claimed as a result of Invokana include diabetic ketoacidosis, stroke, renal failure and other kidney injuries, urinary tract infections, and leg and foot amputations.

After its approval and release in the United States, canagliflozin was the subject of several safety announcements and warning label updates. In May 2017 there was another FDA Drug Safety Communication which confirmed an increased risk of leg and food amputations for those patients taking medications containing canagliflozin. The FDA also required medications containing canagliflozin to have updated warning labels to reflect this risk.

So what should you do if you suffered an injury while taking Invokana? Here are six helpful steps:

1. Don’t Stop Taking Invokana Until You Speak with Your Doctor.

The FDA currently recommends that patients taking Invokana to contact their doctor if they’re experiencing problems with the medication. The FDA has also recommended that patients should not stop taking Invokana until they meet with their doctor first.

I would go a step further and recommend that even if you have no injuries or symptoms, you should ask your doctor if Invokana poses an unnecessary risk to your health. There may be safer medication options for you.

2. See Your Doctor Immediately.

This is the most important thing to do if you are suffering injuries or side effects while taking Invokana. Your health issues must come first. Ask your doctor if Invokana is simply too risky to continue taking. If your doctor insists that you should continue taking Invokana, ask your doctor why (and write down the answers). Also ask your doctor if there are safer alternative medications. Gather as much information as you can. If your doctor does not give the issue the attention you think it deserves, seek a second opinion.

3. Keep a “Symptoms Journal.”

It is simple enough: when you first begin to notice symptoms which seem abnormal or unexpected or troubling, jot down these sensations on a piece of paper or a notes “app” on your smart phone. The more detail the better. This journal may well provide critically important information for your doctors but also for your attorney as he or she prepares a settlement package or a lawsuit. A person who has been injured by a harmful drug can recover money “damages” in a category known as pain and suffering. A symptoms/pain/well-being journal can provide extremely valuable information to an attorney putting together the best case for you in the event you have a viable claim against a pharmaceutical company for a potentially dangerous drug like Invokana.

4. Keep Careful Record of Medical Bills, Out-of-Pocket Expenses, and Time Missed from Work.

Keep accurate records of all bills incurred and any out-of-pocket expenses you are paying for your medical care related to injuries suffered from Invokana, including inpatient treatment, surgeries, recovery, rehabilitation, other medications, etc. In some cases, drug companies will pay the out-of-pocket expenses of a victim of a failed prescription medication. Finally, keep detailed records of all time missed from your employment, including sick days you were forced to spend, and days out of work for which you lost compensation.

5. Find an Attorney You Trust.

This step is very important and not easy. Do your research on the attorney and take your time with this important decision. If the first lawyer you call is not a good fit, you can easily move on to the next lawyer. Of course, you can always call me (919.830.5602).

6. File a Lawsuit Against the Makers of Invokana.

The primary legal argument of the plaintiffs is that Janssen did not adequately warn them or their doctors of the risks associated with taking Invokana. Had these injured people been warned about these risks, they could have chosen an alternative method of treating their Type 2 diabetes.

The Invokana federal lawsuits have been placed into a multi-district litigation, or MDL. The purpose of this consolidation is to allow for a more efficient pretrial litigation process and perhaps facilitate a potential settlement. The cases are currently in the “discovery phase,” which will take several months to complete. The pretrial work must run its course and that can take a while. The discovery process occurs when both sides share information that may be used at trial. In large cases involving corporate defendants like Janssen and J&J, the discovery process can be the most time consuming and expensive part of the lawsuit.

In the Invokana MDL, the judge intends to have three bellwether trial cases chosen by January 2018, with the first bellwether trial beginning in September 2018.

Note: I am not a doctor. As a product liability lawyer, I can’t diagnose your health issues and cannot connect any injury you may have suffered to Invokana or to any other drug. Please see your doctor immediately if you suffer any negative health issue (related to Invokana or another drug).

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose. Instead of the blood glucose staying in the body, it is removed with the body’s urine.

The clinical trials were named CANVAS and CANVAS-R, based on long scientific acronyms. The studies examined the effects of canagliflozin on patients with Type-2 diabetes. The trials discovered that leg and foot amputations occurred twice as often in patients taking canagliflozin as those treated with a placebo.

The risk for amputations broke down like this: 5.9 out of every 1,000 patients treated with canagliflozin suffered amputation, as compared to 2.8 out of every 1,000 patients treated with a placebo. Over a year’s time, the risk of amputation was 7.5 out of every 1,000 patients treated with canagliflozin, compared to 4.2 out of every 1,000 patients treated with a placebo. These are statistically significant results, meaning the risk of amputation for those people taking Invokana was large enough to cause alarm in the medical community.

In the clinical trials, amputations of the toe and middle of the foot were the most common; however, amputations of the leg, below and above the knee, also occurred. Some patients had more than one amputation.

Based on this new data, the FDA ordered new warnings, including a prominent boxed warning, to be added to the canagliflozin drug labels to explain and describe this risk. more Black Box Warnings

A boxed warning is serious business. A “boxed warning” or “black box warning” is a warning that appears on the package insert for certain prescription drugs. It is given this name because the FDA requires that the warning be presented with a box or notable border around the text. The boxed warning is designed to call attention to serious or life-threatening risks that are possible when using the prescription drug.

In July 2017, the FDA required a boxed warning for the diabetes drug Invokana, which included these bullet points:

“Warning: Lower Limb Amputation”

• A 2-fold increased risk of lower limb amputations was observed in two studies of patients taking Invokana.
• Amputations of the toe and midfoot were most frequent; amputations of the leg were also observed. Some patients had multiple amputations.
• Before taking Invokana, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
• Monitor patients receiving Invokana for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.

See FDA Website for the complete boxed warning.

The bottom line: if you are taking Invokana for treatment of Type-2 diabetes, talk to your doctor about the risks and whether you should remain on the medication. For more information, consult the FDA website.

Many things in life involve a cost benefit analysis. We’re constantly taking risks that can cause harm, but choose to take on that risk because the benefits outweigh the dangers. A good example of this is driving a car. There is a risk of getting into an accident, but the benefit of having on-demand personal transportation is easily worth it.

Prescription medications are no different. Each one is intended to provide a benefit, although each will always have at least some side effects or adverse reactions. The question is never, “does the drug have a side effect or adverse reaction?” Rather, it’s “how many side effects and adverse reactions are there and how bad are they?”

It’s no surprise to learn that many medications on the market today have numerous side effects and adverse reactions, some of them deadly. Yet, they’re available for use not only because the benefits may outweigh the risks for a significant number of consumers, but also because the makers of the medication are required to inform consumers of these risks. So a pharmaceutical company that fails to properly warn consumers of the risks of its drugs can get into trouble. That’s exactly the issue with Actemra.more What Is Actemra?

Approved by the US Food and Drug Administration in 2010, Actemra, also known as tocilizumab, is a drug manufactured by Genentech (a subsidiary of Roche). It is used to treat rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and giant cell arteritis. Actemra is most commonly used to help individuals suffering from RA, which is an autoimmune disorder where the body’s own immune system attacks the joints, making them swollen and painful.

What’s the Problem with Actemra?

Actemra has a long list of side effects and adverse reactions that are recognized by the FDA and included in its warnings. Some of these adverse reactions and side effects are:

• Serious infections
• Gastrointestinal perforation
• Severe allergic reactions, including death
• Respiratory tract infections
• Headache
• Increased blood pressure

However, Actemra has recently been discovered to increase the risk of the following:

• Heart attack
• Heart failure
• Stroke
• Pancreatitis
• Interstitial lung disease

These are very serious problems, possibly linked to over 1,100 deaths of Actemra users, according to a recently published STAT investigation. The problem isn’t just that these serious problems exist, but that Actemra does not currently have the necessary strong warnings to inform consumers of the risks. Many similar immunosuppressive RA drugs already on the market, such as Humira (adalimumab), Remicade (infliximab) and Enbrel (etanercept), have similar risks, but unlike Actemra, they have warnings to bring these risks to consumers’ attention.

Actemra was actually marketed by Genentech as an RA treatment with similar effectiveness as Humira, Remicade and Enbrel, but with reduced serious health risks. STAT’s investigation calls this claim into question and raises the potential for a huge number of lawsuits. Essentially, the lawsuits would revolve around a failure-to-warn theory, where the drug maker would be legally liable for not properly warning consumers of a drug’s risks.

Are There Currently any Actemra Lawsuits?

Yes, although the litigation is still in the very early stages. All cases are individual lawsuits with few, if any, settlements or verdicts. Additionally, there is currently no multi-district litigation (MDL) as of yet.

However, this could quickly change as more users of Actemra with injuries come forward, the number of lawsuits rise and the potential legal liability of Genentech becomes clearer. When there are any new developments I’ll make sure to provide you with an update. And if you currently take Actemra, you may want to discuss these recent findings with your doctor. And if you have already suffered injury from Actemra, call me.

This post was written after review of several news sources.

Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five Glock 9s (you don’t), but rather so the gun makers can sell more guns. Mercedes doesn’t make expensive cars because its board of directors hope to improve the world by selling you cars with heated leather seats. Every company sets out first to last to make money. And the more money the better.

So it goes with pharmaceutical companies. The general public may sleepwalk through the concept and lazily presume that the primary motivation for drug companies is to develop medications which cure diseases or which minimize the suffering from diseases. But in fact the motivation for pharmaceutical companies is to make money, and a lot of it. This is rather obvious and not a controversial point, and I’d like to believe that every “BigPharma” corporate board would agree with me. But it helps to keep this profit motive in mind when doing research on drugs you have been prescribed or which you are currently taking. And to be hyper-vigilant about assessing any new “wonder drugs” which hit the market.

“Off-Label” Drug Promotion

Recently, the pharmaceutical industry strenuously objected to new regulations implemented by the U.S. Food and Drug Administration (FDA) on off-label drug uses. Essentially, several advocacy groups supporting the pharmaceutical industry filed petitions opposing heightened restrictions on the marketing and sale of drugs for unapproved or “off-label” uses.

Let’s back up.

There are approved and unapproved uses for prescription drugs. For approved uses, the drug has been thoroughly tested and evaluated. The FDA has determined that the benefits and risks are acceptable and that this determination is backed by “strong scientific data.” Finally, for approved uses, the drugs have labels which set out clearly how to use the drug and for what specific purposes.

Then there are unapproved uses. Once the FDA approves any drug, your doctor is then allowed to prescribe the drug to treat another condition which is not listed as an approved use. Basically, once the FDA green-lights a drug, it relies on competent, unbiased physicians to make the best decisions for their patients in prescribing the drug, for whatever purpose.

Doctors may prescribe a drug for an unapproved use when the doctor believes the drug will help the patient in some way and there is no other drug available to help the patient. The FDA uses the example of a cancer drug approved for one type of cancer, but the oncologist prescribes it to treat a different form of cancer that does not have a similar medication available for treatment.

This sounds reasonably benign, even helpful, but drug companies can be aggressive in promoting off-label use. I have written about troubling off-label uses on this site. One off-label drug use nightmare occurred when doctors prescribed Risperdal for adolescent boys with certain behavior issues. Risperdal was originally approved solely to treat adult patients with schizophrenia. But Johnson & Johnson pressed for FDA permission to market the drug to treat other conditions, such as bipolar disorder and autism, and eventually to permit use in children. It was then expanded further to treat adults and children suffering from attention deficit disorder, anxiety and depression. As it turned out, Risperdal can promote the growth of female breast tissue (“gynecomastia”). Female breasts on adolescent boys is a terrible and traumatic disfigurement. And thousands of lawsuits have resulted from these injuries.

Thus, it is critically important that off-label drug use and off-label drug promotion are monitored carefully. You would think that the pharmaceutical industry would wholeheartedly agree, but . . .

BigPharma Objects to New FDA Off-Label Regulations

The FDA recently published its latest guidelines on regulating off-label drug use. The guidelines give the FDA new authority to police the selling of prescription drugs for unapproved uses. Specifically, the FDA focused on “intended use,” which is “the objective intent of the persons legally responsible for the labeling of drugs.” The goal is to make sure the companies promoting a drug are not pushing for it to be used in an unintended way. Intended use analysis is helpful to the FDA as it “helps the FDA gauge whether companies are intentionally marketing products for unapproved uses.” See FDA Website. The new rule was supposed to give more power to the FDA to hold manufacturers liable for promotion of off-label, unapproved uses of drugs.

The drug industry has objected, calling the new rule a “vague standard” with “no support in existing law.” At the end of the day, the drug companies simply do not want to be held liable for getting caught promoting drugs for off-label use. The industry’s position seems to be “get out of our way and let us make as much money as possible.”

They may get their wish. Recently, President Donald Trump has issued a “regulatory freeze” on all FDA rules and regulations. From what I’ve seen coming out of Washington lately, regulations on BigPharma are likely to get weakened, not strengthened, over the next four years. If you do not do your own research, you may be vulnerable to prescription drugs with unwelcome and harmful side effects.

What to Ask Your Doctor:

If your doctor prescribes a drug for an unapproved use, you should ask:

• What was the drug originally approved for?
• Why am I getting it for my condition?
• Are other drugs available that have been approved to treat my medical condition?
• Do studies support the use of this drug to treat my condition?
• Will this drug work better to treat my medical condition than using an approved treatment?
• What are the benefits and risks of treating my medical condition with this drug?

As always, be careful out there.