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.

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.