Actemra (tocilizumab) is a prescription drug used to treat rheumatoid arthritis. Though it has helped some people manage their disease and improve their quality of life, the drug has been linked to serious medical complications, including stroke, heart attack, and other issues.
There is also suspicion that the makers of Actemra were aware of the risk of complications and failed to warn the medical community and users of the drug.
Study Shows Actemra Users Experience Increased Risk for Cardiovascular Side Effects
According to information from STAT, a medical and scientific discoveries publication, an investigation revealed dangers related to Actemra use. The information was submitted to the FDA and called on the organization to review the information and update warning labels on the drug.
According to the information, users of Actemra experience an increased risk for strokes and heart attacked, and could also develop interstitial lung disease and gastrointestinal tears. STAT reported a 50 percent higher likelihood for users of Actemra to experience a heart attack or stroke.
The FDA has already received thousands of adverse event reports related to Actemra, and more than 1100 of them were for people who had died after using the drug.
Actemra Offered New Hope for Rheumatoid Arthritis Patients
Actemra has been on the market since 2010 and was originally an immunosuppressive medication primarily used to treat polyarticular idiopathic arthritis or systemic juvenile idiopathic arthritis in children ages two and older. It works by blocking part of the immune system and preventing swelling, inflammation, and pain.
It wasn’t approved for treatment of rheumatoid arthritis until May of 2017. Drugs similar to Actemra, including Enbrel, have been linked to similar side effects, but the makers of the drug were hoping the risk would be eliminated with Actemra because Actemra works differently within the body.
Most rheumatoid arthritis drugs block the action of tumor necrosis factor-alpha (TNF-a), a protein involved in triggering inflammation. Actemra, on the other hand, targets interleukin-6 (IL-6), another protein that plays a role in inflammation. People with RA tend to have elevated levels of IL-6. Actemra works by binding to the IL-6 cell receptors and preventing them from triggering inflammation. Actemra was the first to work in this manner when it was introduced in 2010.
Despite the evidence Actemra could be harmful to users, as well as the link between cardiovascular and other side effects and drugs similar to Actemra, the drug does not yet feature a warning label. (Competitor drugs are labeled with the risk.) Critics of the drug are calling on the FDA to require this label be added to Actemra prescriptions.
Actemra Fast-Tracked to Market
Actemra was approved by the FDA for use in treating rheumatoid arthritis through the agency’s fast-track program. This program is an option for drug makers when there is already something similar to the new product on the market. In this case, Actemra was already in use by patients with other conditions, and other drugs similar to Actemra were being used to treat rheumatoid arthritis.
Critics of the program believe too many drugs are released to the public via this method and it is leaving them vulnerable and at risk for serious medical complications, including death.
According to those familiar with investigations into Actemra, the manufacturer was aware of the risk and failed to properly warn the public. Despite the risks linked to similar drugs, the makers of the drug, Roche and Genentech, opted not to add a warning label or to alert doctors to the potential for complications.
If you or a loved one took Actemra and experienced side effects, you might be eligible for compensation. You should not stop using the drug without approval from your doctor.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.