Actemra Lawsuits

Background information on Actemra lawsuit updates published between 2017 to 2018.

Actemra Lawsuits Overview

The Actemra litigation involved claims that the rheumatoid arthritis drug tocilizumab, marketed by Genentech and Roche under the brand name Actemra, caused serious and sometimes fatal side effects that were not properly disclosed to doctors or patients.

Approved to treat rheumatoid arthritis and other inflammatory conditions, the drug was promoted as a safer alternative to competing biologics. However, patients and their families later alleged that Actemra increased the risk of heart attacks, strokes, lung complications, and gastrointestinal perforations without adequate warning labels to reflect those dangers.

As post-marketing reports accumulated, concerns grew that Genentech had failed to update Actemra’s safety information despite internal data and independent studies suggesting higher rates of cardiovascular and pulmonary deaths among users. Lawsuits were filed nationwide claiming the manufacturer misrepresented the drug’s safety profile and failed to conduct sufficient post-approval monitoring.

The litigation sought compensation for wrongful death and personal injury, focusing on whether Actemra’s marketing created a false perception of safety compared to other arthritis treatments.

Actemra Research and Reports

September 27, 2018: Actemra Approved for Use in Children With Juvenile Arthritis

The FDA expanded Actemra’s approval to include children aged two and older diagnosed with polyarticular juvenile idiopathic arthritis. The decision was based on clinical trial data showing reduced inflammation and improved joint mobility, with ongoing monitoring for infection risks.

January 17, 2018: Actemra Side Effects Increase Risk of Blood Loss After Knee Replacement Surgery

A study warned that patients on Actemra undergoing knee replacement surgery experienced greater blood loss than those not taking the drug, likely due to lower fibrinogen levels. This finding added another layer to evolving safety assessments for the arthritis medication in surgical contexts.

December 4, 2017: Actemra, Enbrel, Rituxan Study Suggests Significant Differences Between Clinical Trials and Real-World Outcomes

An observational study compared real-world outcomes for Actemra, Enbrel, and Rituxan, concluding that real-world data may better reflect drug effectiveness and safety than randomized trials. The research underscored potential discrepancies between controlled studies and everyday use for autoimmune therapies.

September 5, 2017: FDA Expands Approval of Actemra Amid Growing Safety Concerns

The FDA broadened Actemra’s approved uses to include managing side effects of CAR-T cell therapy, allowing the drug to reach more patients. Critics noted that this expansion occurred against a backdrop of worries that key safety risks, such as heart attacks and lung disease, were not fully disclosed on the drug’s label.

August 9, 2017: Actemra Study Evaluates Treatment for Systemic Sclerosis

Researchers launched a clinical trial to assess Actemra as a treatment for systemic sclerosis, even as lingering safety questions about the drug persisted. The randomized trial aimed to measure the drug’s impact on disease progression and skin hardening symptoms.

July 28, 2017: Clinical Trial Finds 15% of Actemra Patients Experienced Adverse Effects

A clinical study on Actemra’s use for giant cell arthritis revealed that about 15% of trial participants experienced significant adverse side effects despite the drug’s effectiveness in inducing remission compared to placebo. The results contributed to growing scrutiny of the drug’s long-term safety profile.

May 18, 2017: Study Finds Elevated Infection Risks Among Actemra Users

A post-marketing study identified an increased risk of serious infections, including pneumonia and cellulitis, among patients treated with Actemra. The report underscored the importance of screening for underlying health conditions before prescribing the drug.

April 10, 2017: FDA Issues New Warning About Actemra Side Effects

The FDA updated the Actemra label to include warnings about cardiovascular complications, pancreatitis, and interstitial lung disease after post-marketing reports linked the medication to severe adverse events. Regulators urged healthcare providers to carefully evaluate patient risk factors.