This June 1, 2022 document, “Drug Safety Communication: FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns”, makes clear it is the Ukoniq death risk that was behind the recent Ukoniq drug recall:
Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL).
Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq. As a result, we determined the risks of treatment with Ukoniq outweigh its benefits….
This recent FDA action formalizes an April 15, 2022 announcement by TG Therapeutics Inc. that it is pulling Ukoniq from the market after a study showed a possible increased risk of death in patients using Ukoniq.
In connection with this recent Ukoniq drug recall due to the Ukoniq death risk, we are investigating possible Ukoniq drug injury lawsuits against TG Therapeutics for cases involving patient deaths or serious side effects that may have been caused by Ukoniq.
We encourage you to submit a Case Evaluation Form online – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Ukoniq drug injury case.
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