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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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TOPIC: Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects
AUDIENCE: Patient, Health Professional, Pharmacy, Oncology
ISSUE: The FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer called leukemia and a lymphoma, a cancer found in the lymph nodes. The trial also found Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood.
The FDA is notifying the public of these risks and is continuing to evaluate the safety of Copiktra. The FDA plans to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. The FDA will update the public when more information is available.
For more information about this alert, click on the red button "Read Alert" below.
BACKGROUND: Copiktra was approved to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior therapies that did not work or stopped working.
RECOMMENDATIONS:
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Patients
Patients should talk to your health care professional about the risks and benefits of receiving Copiktra for you. Discuss any questions or concerns you may have, including about possible alternative treatments.
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Health Professionals
Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments. Advise patients receiving Copiktra of the possible increased risk of death and higher risk of serious adverse events.
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Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
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Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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