The U.S. Food and Drug Administration (FDA) has received thousands of reports from patients who suffered serious adverse events associated with the rheumatoid arthritis drug Actemra, and hundreds of people have died while taking the prescription medication in recent years, yet there are no warnings about these risks on the Actemra drug label. If you believe you or someone you love has been harmed by alleged side effects of Actemra, like heart attack, interstitial lung disease or pancreatitis, contact an experienced product liability lawyer as soon as possible to discuss the possibility of filing an Actemra injury lawsuit against Roche Holding AG.
Rheumatoid arthritis (RA) is a painful autoimmune disease that causes swelling and stiffness in joints, and while it typically begins in middle age, it can affect children and young adults as well. A popular treatment for rheumatoid arthritis is Actemra, a prescription medication that, unlike many other arthritis drugs, doesn’t carry warnings about an increased risk of heart attacks and strokes. However, post-marketing reports suggest that Actemra may come with a risk of cardiovascular side effects and other health problems that is as high or higher than similar rheumatoid arthritis drugs. Patients with rheumatoid arthritis who want to avoid such risks may want to consider alternative treatments and therapies that can relieve RA flare-ups and help slow the progression of the disease, such as:
Actemra (tocilizumab) is a blockbuster prescription medication designed to treat moderate to severe rheumatoid arthritis, and is administered as an intravenous infusion on a monthly basis, or as a subcutaneous injection on a weekly or bi-weekly basis. Actemra was first introduced by Swiss drug maker Roche in 2010, and in the years since, the medication been aggressively marketed by the manufacturing company as a breakthrough treatment for rheumatoid arthritis, and has also been prescribed “off-label” to treat as many as 60 other conditions for which it has not been approved by the FDA.
According to a growing body of research, patients with rheumatoid arthritis who take Actemra may face an increased risk of serious and potentially life-threatening health complications. Among the side effects allegedly linked to Actemra treatment are:
Despite claims by Roche that Actemra is a safe and effective option for the treatment of rheumatoid arthritis, researchers have found that Actemra poses an equal or greater risk of heart attack, heart failure, stroke and other potentially life-threatening side effects when compared to similar rheumatoid arthritis drugs. In June 2017, STATNews.com released a detailed review of adverse event reports submitted to the FDA in connection with Actemra side effects, identifying at least 13,500 reports of problems between 2010 and 2016, including as many as 1,128 Actemra-related deaths. The report cites “clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.” Despite these risks, the FDA has yet to require stronger warnings on the Actemra labeling to notify users about the potential for the drug to cause side effects like heart attack, heart disease and pancreatitis. A clinical expert with the FDA even said that, despite uncertainty in the Actemra pancreatitis data, warnings should be added to the drug label “given the potential seriousness of the event,” which in its acute form can kill up to 50% of patients.
Thousands of patients may have already been harmed by Actemra use, and many more may be at risk for problems in the future. Across the country, product liability lawyers are currently reviewing claims of serious injuries on behalf of Actemra users who suffered heart attack, pancreatitis, interstitial lung disease and other problems while taking the drug, and hundreds, if not thousands, of lawsuits are expected to be brought against Roche in the future over complications from the blockbuster rheumatoid arthritis drug.
2008 – At a meeting of FDA scientific advisors debating whether to approve Actemra, a rheumatologist at Boston University voices concerns about the potential for the arthritis drug to cause serious heart problems in users. They ultimately recommend approval of Actemra, with the condition that Roche would sponsor multiyear studies to look for unseen problems and cardiovascular side effects. None of these warnings are added to the drug label.
March 2009 – A report identifies 15 deaths and more than 200 severe side effects in patients in Japan taking Actemra.
2011 – Warnings about “fatal anaphylaxis” are added to the Actemra label, following at least two patient deaths.
2012 – Roche petitions the FDA to expand Actemra’s indications for use among patients who have failed to get relief from only one other rheumatoid arthritis drug, instead of two.
September 2012 – The FDA identifies 258 cases of pancreatitis and 185 cases of interstitial lung disease among Actemra users in clinical trials, epidemiological data and the agency’s own adverse event reporting system.
2013 – The FDA launches a full safety review of Actemra, identifying about 3,500 adverse event reports submitted to the agency as of August 2012, including 118 deaths, 42 of which are linked to cardiac arrest or myocardial infarction.
2014 – A 62-year-old German woman suffers a heart attack and Roche “assessed fatal myocardial infarction as related to (Actemra).”
January 2016 – A report by the Government Accountability Office warns that the FDA is approving too many medications through its 510(k) fast-track approval process, and then failing to adequately monitor them once they enter the market.
May 2017 – Actemra’s approval is expanded by the FDA to include treatment for a form of vasculitis called giant cell arteritis, based on a one-year study that involved just 149 patients who took the medication.
June 2017 – STATNews.com releases a scathing report highlighting about 13,500 reports of side effects involving an Actemra infusion or injection submitted to the FDA between 2010 and 2016, including at least 1,128 deaths.
October 2016 – In a study comparing Actemra to Enbrel, which carries warnings about the potential risk of cardiovascular disease and heart failure, researchers find a 1.5-times increased risk of stroke and heart failure among Actemra users.
May 2017 – A study published in the Journal of the American Medical Association warns that one-third of all drugs approved by the FDA are later required to update their labels or are recalled from the market due to adverse side effects.
June 2017 – In a study published in the journal Arthritis & Rheumatology, researchers find nearly identical rates of strokes and heart attacks among patients taking Actemra and other rheumatoid arthritis medications.
When Actemra first entered the market, there were several other rheumatoid arthritis drugs already available, including Humira, Remicade and Enbrel, and while these medications carried strong warnings about their potential for causing serious cardiovascular side effects in users, the Actemra label contained no such warning. As a result of Roche’s failure to include adequate warnings about the possible side effects of Actemra, patients and healthcare professionals were led to believe that the drug was safer than the available alternatives, which recent research has proven otherwise. While hundreds of people have died from alleged Actemra side effects, and thousands of others have suffered devastating complications while taking Actemra, Roche has gotten rich off its blockbuster arthritis drug, which generated $1.7 billion in sales in 2016 alone. Future Actemra lawsuits brought against Roche in will likely accuse the company of the following:
The rheumatoid arthritis drug Actemra has been linked to a higher-than-expected number of serious and potentially life-threatening side effects when compared to other arthritis medications, many of which carry warnings on their labels about adverse events like heart attack, stroke, lung disease, heart failure and wrongful death. If you or a loved one took Actemra and you have since suffered a serious medical complication, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by defective pharmaceutical drugs, and can help put you in touch with an attorney who has experience handling Actemra injury claims.