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  5. Drug Safety Oversight Board (DSOB) Meeting July 25, 2022
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board (DSOB) Meeting July 25, 2022

Public Summary

The following 3 Drug Safety Communications were posted since the March 15, 2022 DSB meeting.

  • March 30, 2022 (update to November 17, 2015 DSC): FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
    • FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine for X-rays and other medical imaging procedures.
    • FDA’s review showed that underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon.
    • FDA has approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. These risks and recommendations pertain to ICM given as an injection through an artery or vein.
  • June 1, 2022 (update to February 3, 2022 DSC): FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concerns
    • Due to safety concerns, FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).
    • Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq
  • June 30, 2022: FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
    • 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 leukemia and lymphoma.
    • The trial 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.
    • FDA is notifying the public of these risks and are continuing to evaluate the safety of Copiktra.
    • 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.

There was one presentation to the Board: Briefing on Psychedelics Landscape and Drug Development (Jamie Gamerman, J.D., Regulatory Counsel, Office of Medical Policy and Jean Kim, M.D., Lead Physician, Division of Psychiatry)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

Additional Information

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