From this June 30, 2022, FDA Drug Safety Communication, “FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)”, we get the following: To evaluate the long-term safety of Copiktra, we required the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical … [Read more...]
Ukoniq Death Risk is Reason for Ukoniq Drug Recall Says FDA
This June 1, 2022 document, “Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns”, makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall: Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer … [Read more...]
Ukoniq Withdrawn From Market Due to Increased Risk of Patient Deaths
The drug company responsible for the lymphoma medicine Ukoniq (umbralisib), TG Therapeutics, indicated in April 2022 that Ukoniq was withdrawn from the market due to an increased risk of death in patients using Ukoniq. This April 15, 2022 Dow Jones piece, “TG Therapeutics Pulls Sole Product Ukoniq Amid Increased Death Risk”, summarizes why … [Read more...]
April 2022 FDA Advisory Committee Meeting For Ukoniq Risk of Death
We first learned from this March 10, 2022 press release item, “TG Therapeutics Announces Scheduling of Planned Oncologic Drug Advisory Committee Meeting”, that the Ukoniq FDA Advisory Committee meeting will be held on April 22, 2022. This development relates back to a Drug Safety Communication, “FDA investigating possible increased risk of death … [Read more...]
Possible Ukoniq Drug Recall Due to Increased Risk of Death
Ukoniq (umbralisib) was approved by the FDA in February 2021 to treat adults with two types of lymphoma cancer that have returned or it did not respond to prior treatment: Marginal Zone Lymphoma (MZL); and, Follicular Lymphoma (FL). Only a year later, however, there is a new FDA Ukoniq safety investigation after a so-called “safety signal” … [Read more...]