Failure to Warn About Actemra Health Risks
Actemra (tocilizumab) is a popular rheumatoid arthritis drug, which was introduced by Roche in January 2010 as a “unique” breakthrough treatment. Amid aggressive marketing, it has grown to become a blockbuster drug, generating sales of $1.7 billion per year.
Since the drug did not contain certain warnings found on competing rheumatoid arthritis drugs, many users and doctors assumed Actemra was safer. However, based on problems experienced by users throughout the United States, this does not appear to be the case.
Reports suggest that side effects of Actemra may cause users to face the same, or even a greater, risk of suffering serious injuries, including:
- Heart Attack
- Heart Failure
- Interstitial Lung Disease
- Wrongful Death
The Actemra attorneys at Saiontz & Kirk, P.A. are reviewing potential cases for individuals who have suffered injuries that may have been avoided if accurate warnings had been provided about the risks associated with Actemra. Lawsuits may provide settlements or financial compensation for you and your family. Request a free consultation and claim evaluation.
Actemra was the first member of a new class of rheumatoid arthritis treatments, known as IL-6 receptor inhibiting drug. It was the first medication designed to specifically inhibit the biological activity of IL-6, levels of which are elevated among individuals with RA.
Two different variations of the drug are marketed by Roche and it’s Genentech subsidiary
- Actrema Infusions: administered intravenously on a monthly basis, taking about an hour for each infusion. Actrema intravenous infusions are available in 80mg per 4 ML; 200 mg per 10mL; and 400 mg per 20 mL doses.
- Actemra Injections: administered at home weekly or biweekly as a subcutaneous injection from a single-use syringe with 162 mg in .9 mL dose.
Rheumatoid arthritis (RA) is an autoimmune disease that affects about 1.5 million Americans. It causes pain, swelling and stiffness in joints. Unlike osteoarthritis, which is caused by damage to the joints, RA occurs when your own immune system attacks the linings of the joints. This can eventually lead to bone erosion and deformed joints, and can lead to the damage of other parts of the body also.
Actrema is only approved for use in situations where other rheumatoid arthritis treatments have failed. Roche sought wider use of their drug in 2012, obtaining approval to market Actemra for individuals who failed to get relief from only one other drug, as opposed to two.
In May 2017, approval was again expanded to allow use of Actemra to treat giant cell arteritis, which is also commonly referred to as temporal arteritis, impacting the arteries in the head and neck. Giant cell arteritis involves inflammation of the blood vessels that is an autoimmune disease, like rheumatoid artheritis.
Since it was introduced, concerns have existed about the sufficiency of Actemra studies, since only short-term clinical trials were used to justify the approval of the drug. As a result, multi-year studies were a condition of approval, and Roche had an obligation to monitor for reports of adverse events involving problems that were not detected during the initial Actemra research.
Although other competing rheumatoid arthritis drugs, such as Humira, Enbrel and Remicade, contain important warnings about the risk of cardiovascular problems, pancreatitis, lung disease and other health complications, Actemra warnings did not provide the same information for users and the medical community.
As a result of the false and misleading information provided by Roche, doctors were mislead into believing Actemra is safer, because side effects associated with competing drugs were not indicated on the label.
According to adverse event reports submitted to the FDA since Actemra was introduced, it appears that the rates of certain Actemra complications were as high or higher than what has been seen with other, more widely used rheumatoid arthritis drugs. As a result, serious questions have been raised about why Roche withheld information from the warning label when Actemra infusions and Actemra injections were sold in recent years.
STAT Investigation Into Actemra Reports
In June 2017, the national publication STAT released an investigative report, analyzing thousands of adverse event reports received by the FDA from 2010 to 2016. The findings raise concerns about the failure to warn about Actemra risks.
The analysis included 13,500 cases submitted to the FDA Adverse Event Reporting System (FAERS), including at least 1,128 deaths and thousands of serious side effects linked to Actemra.
Although Humira, Remicade and Enbrel are much more widely used, and contain warnings that are missing from Actemra, side effects identified in the STAT report indicate:
- Actemra lung disease cases were about the same as Humira, and more common than with Remicade, even though each of these competing drugs contain warnings about the risk of interstitial lung disease missing from Actemra;
- Actemra heart failure and stroke rates were about 1.5 times higher than what was seen with Enbrel, which contains high profile heart warnings;
- Actemra pancreatitis cases were identified in 132 reports, including 26 deaths;
Rather than providing updated warnings or issuing an Actemra recall based on the adverse event reports submitted in recent years, Roche continued to market their drug as a safer rheumatoid arthritis drug. As a result, financial compensation may be available through a class action or individual lawsuit for individuals who have experienced an injury.
Actemra Side Effects Lawsuits
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations to help individuals determine whether they may be entitled to financial compensation as a result of Roche’s failure to warn about Actemra side effects.
All Actemra infusion or injection cases are pursued under a contingency fee agreement, which means that there are no out-of-pocket costs to hire our law firm, and we never receive any attorney fees or reimbursement for expenses associated with the case unless a settlement or recovery is obtained.
After contacting our office to review your Actemra failure to warn claim, we will obtain information regarding the circumstances surrounding the use of Actemra and injury experienced to help determine whether you may be eligible for financial compensation. However, it remains your decision whether to hire our law firm to pursue your case.
Protect your family, and contact Saiontz & Kirk, P.A. today to evaluate what legal options may be available.