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What if a doctor prescribed you a drug without telling you about all of the side effects? What if that doctor wasn’t even aware of all of its potential side effects? In recent years, patients recommended Actemra, a drug designed to treat rheumatoid arthritis (RA), found this scenario unfolding. Some who started the medication soon developed heart attacks, strokes and heart failure, with many of these conditions becoming fatal.

As a result, Actemra has been associated with, but not directly linked to, hundreds of deaths. Since medical publication STAT News identified the correlation, many patients have started coming forward to file lawsuits against manufacturers Roche and Genentech.

Background

Falling under the category of humanized interleukin-6 receptors, Actemra (tocilizumab) assists adults living with moderate to severe active rheumatoid arthritis. The FDA approved it for this use in 2010, and since then, doctors have recommended it to over 760,000 patients. Additionally, the FDA has since approved it for Juvenile Idiopathic Arthritis and doctors further prescribe it for roughly 60 other off-label uses.

Upon its approval, Roche and Genentech painted the drug as a next-generation solution, one allegedly without life-threatening side effects and a safer alternative to NSAIDs like Vioxx, which has since been taken off the market. Yet, research, showed this not to be the case, even before the FDA approved Actemra. In 2009, the Wall Street Journal reported on a study of 5,000 Actemra users in Japan conducted by Roche subsidiary Chugai Pharmaceutical. Results associated 15 deaths from this group – a rate on par with existing RA drug Enbrel – directly with Actemra usage.

Seven years later, the American College of Rheumatology again compared the two medications. This time, researchers found that patients on Actemra had heart attack risks 1.5 times greater than those taking Enbrel. The only difference was that Enbrel warned users, while Actemra came with no such statement.

Investigation

In 2017, STAT News released an investigation that analyzed 500,000 reports of side effects related to RA drugs. Researchers determined that Actemra, which carries no label warning about potential cardiovascular and pulmonary effects, comes with higher heart attack and stroke risks when compared to its competitors.

More specifically, the FDA received 1,128 reports from 2010 through 2016 about deaths related to Actemra, including from cardiac arrest, pancreatitis, strokes and interstitial lung disease. After comparing these figures to those for Humira, Remicade and Enbrel, researchers determined that Actemra users have a 50-percent greater chance of experiencing a stroke or heart attack and have higher risks of developing lung disease.

Yet, even with these findings, the FDA still has yet to release a warning or a recall, although the organization has assessed Roche’s practices. For one, the FDA doesn’t verify every adverse-event report. Secondly, it claims that it can’t determine a direct association between Actemra use and the development of these conditions, on the grounds that patients with RA are already more susceptible to heart disease and that most arthritis drugs come with some kind of cardiovascular risk.

In response, the FDA claims the STAT study doesn’t provide enough evidence to justify Roche updating its warning label. Furthermore, as of May 2017, the FDA went ahead to approve Actemra for treating giant cell arteritis.

Lawsuits

Although, as of 2017, there’s no pending multi-district litigation, patients have begun filing their own claims against Roche and Genentech, alleging that both companies:

  • Failed to warn doctors and patients of all side effects.
  • Negligently advertised their drugs by making false allegations about safeness and a lack of side effects.
  • Led to doctors’ over-prescription of Actemra, including to patients prone to heart and lung conditions.
  • Never properly tested the drug before placing it on the market.
  • Concealed key information about Actemra’s risks from the FDA; and
  • Misrepresented its safety in articles and marketing materials.