The chemotherapy drug Zydelig decreases white blood cell counts and increases the risk of pneumonia and other severe infections. In March 2016, drug-makers halted six clinical trials after several patients died.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Zydelig induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a severe infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
Gilead Sciences gained approval for Zydelig (idelalisib) in July 2014. It is a first-in-class drug that is used to treat three types of B-cell blood cancers that have returned after other treatments failed. Zydelig is used in combination with rituximab for chronic lymphocytic leukemia (CLL). It also treats non-Hodgkin lymphoma (FL) and small lymphocytic lymphoma (SLL).
What is the problem?
March 14, 2016 — The FDA is warning that six clinical trials investigating Zydelig as a first-line treatment for leukemia were stopped prematurely after several patients died. Zydelig is not approved as a first-line treatment for CLL.
European Health Officials Issue Warnings
The European Medicines Agency (EMA) is recommending that cancer patients on Zydelig receive antibiotics to prevent lung infections known as Pneumocystis jirovecii pneumonia. Patients should also be monitored for infection and have regular blood tests to check white blood cell counts. Low counts are a common side effects of Zydelig that can increase the risk of infection.
Pneumonia Symptoms
Pneumocystis jirovecii pneumonia is a lung infection caused by a fungus that is commonly found in the environment. Symptoms include:
- Cough, often mild and dry
- Fever
- Rapid breathing
- Shortness of breath, especially with activity (exertion)
Cytomegalovirus Infections
European health officials warn that patients on Zydelig may also face an increased risk of infection with cytomegalovirus (CMV). Most adults over age 40 are infected with this virus, but it rarely causes problems unless their immune system is weakened. Symptoms may include:
- Sore throat
- Swollen lymph nodes
- Fever
- Headache
- Fatigue
- Weakness
- Muscle aches
- Loss of appetite
Zydelig “Black Box” Warning Label
The label on Zydelig includes a “Black Box” about the risk of liver toxicity, diarrhea and colon inflammation (colitis), lung inflammation (pneumonitis), and intestinal perforation.
Common Side Effects of Zydelig
Pneumonia and low white blood cell counts are two of the most common side effects of Zydelig, according to the FDA. Other common side effects are diarrhea, fever, fatigue, nausea, cough, abdominal pain, chills, rash, high levels of triglycerides in the blood, high blood sugar (hyperglycemia), and elevated levels of liver enzymes.
Zydelig Class Action
Class actions are useful in some circumstances, but they can also have disadvantages. They are designed to maximize efficiency rather than compensation for plaintiffs with the most severe injuries. Instead of a Zydelig class action, we are filing individual lawsuits on behalf of people who were diagnosed with severe infections or other side effects.
Do I have a Zydelig Lawsuit?
The Schmidt Firm, PLLC is currently accepting Zydelig induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a severe infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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