Four Canadian trials involving the cancer treatment medication Zydelig (generic: idelalisib) have been stopped after the drug was linked to an increased rate of adverse events, including death.
Free Confidential Lawsuit Evaluation: If you were harmed by Zydelig side effects, or a loved one died after taking the medication, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
March 17, 2016 – In addition to the 4 halted trials, 3 other studies will be amended by implementing additional measures to ensure patient safety, Health Canada announced today. All of the trials were exploring the use of “Zydelig in patients with different disease characteristics or with different drug combinations than those for which Zydelig is currently approved for use in Canada.”
Health Canada is working with study sponsors to help ensure that all Canadian participants are notified, and trial site investigators have been made aware of the new safety issues. Patients enrolled in Zydelig clinical trials should consult their physician immediately. Health Canada is also performing a review of the drug and will take appropriate steps as needed.
Updated information only applies to changes in the Zydelig risk profile under clinical trial situations. Patients taking the drug for illnesses outside of a clinical trial setting should talk to their doctor before changing medications or discontinuing treatment.
Zydelig received approval from Health Canada in April 2015 for the treatment of relapsed chronic lymphocytic leukemia (blood and bone marrow disease). It may also be prescribed to patients with follicular lymphoma who have previously been treated with other drugs.
In Canada, Zydelig labels warn about the risk of a decrease in certain white blood cells (neutrophils), and recommends blood count monitoring. Certain kinds of infections are also noted in the product labeling.
Do I Have a Zydelig 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 Zydelig lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Zydelig side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.