For the 1.5 million Americans that suffer from rheumatoid arthritis, Actemra may seem like a miracle drug. However, many patients and researchers have voiced their concern about the link between Actemra and many deadly side effects while none of those risks are listed on the Actemra FDA label.

Actemra, generically known as tocilizumab, was approved in January 2010 by the U.S. Food and Drug Administration for the treatment of rheumatoid arthritis (RA) and in 2014, it was approved to treat children for systemic juvenile idiopathic arthritis.

Actemra is also prescribed off label, according to STAT, for about 60 other conditions. Genentech, a division of drug maker Roche, reports that Actemra grossed sales of about $1.7 billion in 2016 and is used by over three quarters of a million patients.

Patients report that the reason they have opted to take Actemra as opposed to other rheumatoid arthritis drugs is that the Actemra FDA label did not mention severe risks. Risks of heart attacks, heart failure, or life-threatening lung complications have been associated with other RA drugs, but not Actemra initially.

However, reports of Actemra patients dying from heart problems and cardiovascular disease, lung conditions and pancreatitis have been seen as possibly being connected to Actemra use.

STAT analyzed 13,500 FDA Adverse Events Reporting System (FAERS) reports and discovered that, when compared with other RA drugs, Actemra showed higher than expected numbers of serious problems.

The problem also lies with the Actemra FDA label. For example, about the same amount of incidents of interstitial lung disease are reported in both Actemra and Humira users, with Remicade reporting an even higher amount. However, both Humira and Remicade have this listed as a possible side effect on their label. The Actemra FDA label does not.

Heart attacks, strokes and heart failure show similar results. Yet, the Actemra FDA label does not list any of these conditions as possible risks.

Other potentially life threatening side effects that are not listed on the Actemra label but have been connected with the drug include pancreatic cancer, infection and gastrointestinal perforation.

The FDA has received 1,128 reports, according to STAT, connecting patient deaths with Actemra. The FDA has reviewed its safety several times, but says that they do not have sophisticated enough tools to determine if Actemra caused these deaths or not.

Many believe the system for drug approval is broken, and that while it has become easier to approve drugs, often there is little follow-up to see if the drug is performing as it should after approval.

Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University told STAT, “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective. The system is broken, and all the financial incentives are lined up to keep it broken.”

If you or someone you love has experienced heart or lung conditions while taking Actemra and believe you should have been informed of these risks by the Actemra FDA label, you may be eligible to file a lawsuit.

In general, Actemra lawsuits are filed individually by each plaintiff and are not class actions.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. Hurry — statutes of limitations may apply.

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