Unlisted Side Effects from Actemra? You May Be Eligible to Compensation

Advertisements for drugs on television and in publications enumerate long lists of the medication’s potential side effects.  While this can be daunting, at least consumers can consider themselves warned about what they may encounter if they take the medication.  They can look for symptoms, and physicians can help them deal with any problems which may result.  A much worse scenario is when a drug has the potential to cause serious or fatal complications and there is no caution of these problems on the warning label.  Such is the case with Actemra, one of the most popular drugs for patients suffering from rheumatoid arthritis (RA).

Relief from Rheumatoid Arthritis

RA affects around 1.3 million Americans, which means there are many patients actively seeking relief from this debilitating disease. RA causes chronic pain and swelling, and can be difficult to treat.  Some estimates suggest that 60% of patients who do not get proper treatment for this autoimmune disease will no longer be able to work within ten years of onset.

While there is no cure for RA, there are four different classes of drugs currently used to treat the symptoms: nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, disease-modifying anti-rheumatic drugs (DMARDs), and biologic response modifiers (biologic DMARDs) which are often used in conjunction with DMARDs.

A Breakthrough Drug

As a biologic DMARD, Actemra (tocilizumab) falls into the newest class of RA drugs.  It is designed to inhibit the specific part of the immune system that fuels the kind of inflammation that feeds RA.  Actemra is often prescribed when patients have moderate to severe forms of the disease and have not responded well to other medications. Introduced in 2010 in the United States, Actemra has now been prescribed to more than 760,000 patients around the globe and has generated $1.7 billion in sales for Roche, its manufacturer.

Side Effects

Along with Actemra’s benefits come numerous potential side effects it does describe in its Starter Kit Book.  The side effects include:

• 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
• Injection site reactions

However, unlike similar drugs, Actemra does not list the risk of heart attacks, heart failure, or life-threatening lung problems in its side effects list.  Other unlisted side effects of the drug have been reported by numerous patients to include cognitive problems, pancreatitis, small strokes, heart rhythm tachycardia, and tremors.

Patients Misled

In 2017, Stat News issued a report which claimed that hundreds of people taking the drug have died from these “unlisted” complications, with many more suffering impairment or injury. It goes on to state that these complications were as high or a higher risk for patients taking Actemra than for its competitor drugs.

Stat News concludes that Actemra’s side effect list is not sufficient, and that the “risk to patients might be greater than they are led to believe”.  It also reports that the U.S. Food & Drug Administration (FDA) has received reports of at least 1,128 patients dying after using Actemra.  Unfortunately, neither the FDA nor Roche have changed the drug’s labeling to reflect these additional serious risks.

The result is that patients and doctors may believe that Actemra is safer than its competitors.  There may be a false sense of security that the side effects are “not that serious”, so patients can take it with little reason to worry.

Your Legal Options

If you or someone close to you have suffered serious complications from Actemra, you should contact your health care provider, and possibly file a report of side effects with the FDA.  Drug manufacturers are not allowed to mislead patients about potential serious side effects related to the drugs they produce.