When launched in the United States in 2010, rheumatoid arthritis medication Actemra promised a low risk of side effects and breakthroughs for patients. Now, just seven years later, numerous Actemra lawsuits loom after failure to warn patients about possible side effects has resulted in thousands of injuries and deaths.
At Brown & Brothers, we are passionate about informing our readers of any dangerous drugs and helping those injured protect their legal rights. Read on to learn more about Actemra, the potential risks, Actemra lawsuits, and what to do if you have been harmed by a dangerous or defective drug.
The Unfulfilled Promise of Actemra
Rheumatoid arthritis (RA) affects about 1.5 million Americans. Many of the medications used to treat the disabling symptoms have very serious side effects and potential risks, which is why Actemra offered so much promise when it hit U.S. markets. Unlike other RA medications, Actemra was not associated with serious side effects like heart failure, heart attack, or lung complications. In fact, the Actemra label does not include warnings about these potential side effects on the label.
Since Actemra was first manufactured, over 760,000 people worldwide have been administered the drug, either by injection or intravenously. Last year, the manufacturer sold $1.7 billion for Actemra usage. Though primarily used to treat RA, reports note that there are around 60 “off-label” conditions that doctors may prescribe Actemra to treat. These off-label conditions have not completed testing for safety or effectiveness, and are not approved for those uses.
National publication, STAT, published a report in June 2017 detailing an investigation into 500,000 side effect reports related to RA medications and potential side effects. With no association or warning label about potentially deadly side effects, doctors and consumers alike were startled at results indicating that patients taking Actemra had “as high or higher” risk of heart attack, stroke, heart failure, and other dangerous side effects as individuals taking any other RA medications.
Further investigation reveals that the U.S. Food and Drug Administration (FDA) alone has received 1,128 reports of deaths among patients taking Actemra. In response, the FDA has reviewed the safety of the drug on more than one occasion. Lacking the proper tools to determine whether the drug itself caused the deaths, or if it was merely a bystander, the FDA has not taken action to revoke approval.
Lack of Monitoring and Action
The FDA is charged with monitoring prescription drugs, their safety, and managing reports of side effects. Unfortunately, the agency is not equipped to verify every report, and report documents often lack key information about the adverse events. Consider the following adverse reports:
- A 73-year-old man received intravenous Actemra and suffered a fatal brain bleed two days later. His doctor ruled that “no other factor other than the drug could have explained” the injury and death.
- In response to a 62-year-old German patient’s heart attack in 2014, Roche, the manufacturer of Actemra, “assessed fatal myocardial infarction as related to (Actemra)”.
Though Roche and the FDA have numerous reports of adverse or fatal events, and clinical studies have also measured the dangers, neither have moved to change the label to alert doctors and patients about the risks. This failure to warn doctors and patients has been said to highlight the FDA’s “inability to adequately scrutinize the safety of drugs after they have been approved”.
Experts are more concerned than ever about the ease of approving drugs, the lack of monitoring for safety and effectiveness, and the fact that financial incentives protect drug manufacturers and ensure that the system is broken. The system is, in fact, operating on the idea of approving drugs quickly, then waiting to catch safety or efficacy problems down the road.
Actemra Lawsuits Looming
The heart of issues like those surrounding Actemra is the damage done to patients and their loved ones. Numerous patients and families have come forward expressing how the failure to warn about devastating side effects of Actemra has changed their lives for the worse. Patients feel lied to, with many losing trust in their doctors and the medications supposedly designed to help them live a better quality of life.
Because Roche and the FDA are doing nothing to correct the deficiencies in warning patients, numerous Actemra lawsuits are pending. So far, there are numerous individual lawsuits, mass torts, and class action lawsuits pending. The goal of Actemra lawsuits is to provide patients and their loved ones with compensation for the harm caused. While no amount of financial compensation can replace the life of a loved one, or restore what was lost due to harmful side effects, it can help patients and their families recover:
- Economic damages for medical or funeral expenses, lost wages, or lost earning capacity
- Noneconomic damages like pain and suffering, emotional harm, or loss of consortium
- In cases where the manufacturer knew the risks and still failed to warn patients, punitive damages may also be pursued.
Anyone who has been administered Actemra who has suffered adverse side effects should contact a medical malpractice attorney right away. Let the skilled team at Brown & Brothers work on your behalf to protect your rights, make your voice heard, and get you the justice and compensation you deserve.
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