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Amid growing concerns about the potential side effects of Actema, a new-generation rheumatoid arthritis drug that has been linked to reports of heart attacks, strokes, pancreatitis and other injuries, the manufacturer is pushing for expanded use of the medication.
According to an update posted last month on clinicaltrials.gov, Roche is moving forward with a clinical trial to examine whether Actemra would be effective in treating systemic sclerosis.
Actemra (tocilizumab) was introduced in 2010, as a second-line treatment for rheumatoid arthritis, in severe cases where individuals have not responded to other drugs. In May 2017, the FDA approved expanded use to treat giant cell arteritis, and the medication has grown to generate over $1.6 billion in annual sales
Since the medication was marketed without warnings about certain health risks commonly linked to competing rheumatoid arthritis drugs, such as Humira, Remicade and Enbrel, many doctors and patients have assumed Actemra is safer. However, recent reports suggest that users may face the same, or higher risks.
A recent independent review of adverse event reports submitted to the FDA identified a higher-than-expected number of severe injuries, including heart attacks, strokes, heart failure, interstitial lung disease and pancreatitis. In addition, the drug has been linked to at least 1,128 deaths since 2010. As a result, some are calling for Actemra warnings to be added, which may cut into sales.
A number of product liability lawyers are now reviewing the potential for Actemra lawsuits for individuals who have experienced problems, suggesting that Roche new or should have known that the drug carried similar risks to other rheumatoid arthritis drugs, but withheld information from the label to create a false impression that their drug was safer.
Adding to the Actemra problems for Roche, a study published last month in the medical journal Rheumatology found that individuals with a specific type of rheumatoid arthritis (RA), known as anti-citrullinated protein antibody (ACPA) negative, face a higher risk of infections than those with ACPA-positive rheumatoid arthritis.
These recent concerns have not stopped the manufacturer from continuing with efforts to get the FDA to approve more uses for Actemra. The study currently underway involves a randomized double-blind trial including 212 participants, half of whom will be given Actemra and half of whom will be given a placebo to see if there is a significant effect on symptoms of systemic sclerosis.
Primary completion date of the study is expected to be in January, with final completion scheduled for February 2019. Patients will have been on the drug for 48 weeks by the time the study is completed.