Update: FDA Approves Actemra to Treat Complication of CAR T Cell Tx
August 31, 2017 – The FDA has approved Actemra for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients aged ≥2 years, Genentech has announced. This marks the first FDA-approved treatment for this indication.
Actemra (tocilizumab injection) works by reducing the effects of a substance in the body that causes inflammation. The medication has received approval from the U.S. Food & Drug Administration (FDA) to treat:
- Moderate to severe rheumatoid arthritis in adults
- Active systemic juvenile idiopathic arthritis (SJIA)
- Polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older
- Giant cell arteritis
What’s the Problem?
A STAT News Investigation published June 5, 2017, found that hundreds of patients who took Actemra had died from cardiovascular and pulmonary complications – side effects the drug had not previously been linked to.
According to the report, Actemra does not warn about these side effects on the labeling, unlike many competing RA drugs. Stat said it investigated more than 500,000 side effect reports for RA drugs and “found clear evidence” that the risks of side effects including heart attack and stroke “were as high or higher for Actemra patients than for patients taking some competing drugs.”
FDA has received at least 1,128 death reports in patients treated with Actemra, according to STAT. However, the agency has been unable to determine if the drug was a direct cause due to a lack of “sophisticated tools.”
Actemra Side Effects
- Heart failure
- Heart attack
- Interstitial lung disease
- Other life-threatening lung complications
- And more
Actemra Side Effects Lead to Thousands of Lawsuits: Ring of Fire Video
About Class Action Lawsuits
Although we are a nationally recognized class action firm, the Products Liability Litigation Group at our law firm has decided against the filing of an Actemra class action suit and is currently filing individual claims on behalf of individuals and/or their family members that have been injured by Actemra.
A class action is a type of lawsuit filed with the court on behalf of large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Law Firm Is Filing Individual Lawsuits Opposed To a Class Action
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees. At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Actemra lawsuits on their behalf.
Do I Have an Actemra Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actemra lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Case Evaluation: Again, if you harmed by Actemra side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.