In continuation to the recent drug safety communication for umbralisib in Feb-2022, USFDA further released a drug safety communication pertaining to the withdrawal of approval for umbralisib.

Ukoniq (umbralisib) is a cancer medicine used in the treatment of below two specific types of lymphomas. It is a PI3 kinase inhibitor, which controls the multiplication and spreading of cancer cells by blocking the signaling action of abnormal protein.

  1. Marginal zone lymphoma (MZL)
  2. Follicular lymphoma (FL)

Latest results from UNITY clinical trial continued to show a possible increased risk of death patients receiving umbralisib. Manufacturer of this product [TG Therapeutics] determined that the risks of using this product outweighs its benefits [unfavorable benefit-risk ration] and voluntarily withdrawn product from the market for the approved uses of MZL & FL and limited its use only to patients with favorable benefit-risk profile through expanded access.

Healthcare professionals are required to stop prescribing/dispensing/administering this medicine and look for alternative treatments.

Patients are required to discuss with their respective healthcare professional about the alternatives before stopping this medicine and dispose the unused medicine safely into home trash.

Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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