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EMA Issues Zydelig Safety Guidance Following Patient Deaths

The European Medicines Agency (EMA) has issued new safety guidance for use of the cancer medication Zydelig (generic: idelalisib) after it was linked to adverse events, including multiple deaths, during clinical trials.

Free Confidential Lawsuit Evaluation: If you were injured by Zydelig side effects, or a loved one died after being treated with the drug, 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 22, 2016 – According to EMA’s new guidelines, cancer patients are to receive antibiotics while undergoing treatment with Zydelig in order to prevent a lung infection known as pneumocystis jirovecii pneumonia (PJP). The agency also recommended that physicians monitor white blood cell levels for signs of PJP infection. Gilead Sciences Inc., the company that makes Zydelig, had previously announced that it was halting 6 clinical trials for the drug, including 3 trials flagged in EMA’s initial review.

Zydelig was approved by the European Union (EU) in Sept. 2014, and has since been used to treat follicular lymphoma, and in combination with Rituxan (generic: rituximab) for the treatment of chronic lymphocytic leukemia (CLL). However, the recent adverse event reports may have put Gilead’s development program for additional uses on hiatus.

Zydelig Black Box Warning

When the U.S. Food & Drug Administration (FDA) approved Zydelig under and expedited review process, the approval required that its labeling carry a black box warning (PDF) regarding the potential for infection-related deaths. Specifically, the warning states that:

  • Fatal and/or serious hepatotoxicity occurred in 14% of Zydelig-treated patients.
  • Fatal and/or serious and severe diarrhea or colitis occurred in 14% of Zydelig-treated patients.
  • Fatal and serious pneumonitis can occur in Zydelig-treated patients.
  • Fatal and serious intestinal perforation can occur in Zydelig- treated patients across clinical trials.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is continuing to investigate the safety of Zydelig in order to solidify its guidance on use of the drug. However, it should be noted that the 3 trials included in EMA’s safety review were exploring the use of Zydelig in a different manner from its current authorization.

Do I Have a Zydelig Lawsuit?

The Pharmaceutical 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 or a loved one was injured by Zydelig, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

Free Confidential Case Evaluation

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