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  5. Drug Safety Oversight Board (DSB) Meeting June 26, 2024
  1. Center for Drug Evaluation and Research (CDER)

Drug Safety Oversight Board (DSB) Meeting June 26, 2024

Public Summary

The following 5 Drug Safety Communications were posted since the July 25, 2022 DSB meeting:

January 19, 2024 (update to 11/22/2022 DSC): FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)

  • This warning and new labeling contains information to help reduce this risk, including appropriate patient selection for Prolia treatment, increased monitoring of blood calcium levels, and other strategies.

January 11, 2024: Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity

  • FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists. FDA’s preliminary evaluation has not found evidence that use of these medicines causes suicidal thoughts or actions. FDA is continuing to look into this issue and will communicate their final conclusions and recommendations after they complete their review or have more information to share.

November 11, 2023: FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)

  • FDA is requiring manufacturers of these medicines to add new warnings about Drug Reaction and Eosinophilia and Systemic Symptoms (DRESS) to the prescribing information and the Medication Guide for patients and caregivers.
  • The warnings for both levetiracetam and clobazam medicines will include information that early symptoms of DRESS such as fever or swollen lymph nodes can be present even when a rash cannot be seen.

May 11, 2023: FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

  • To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, the U.S. Food and Drug Administration (FDA) is requiring updates to the prescribing information.
  • This includes adding information that patients should never share their prescription stimulants with anyone. The Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class. It will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

April 13, 2023: FDA updates prescribing information for all opioid pain medications to provide additional guidance for safe use

  • These updates include:
    • Stating that immediate-release (IR) opioids should not be used for an extended period unless the pain remains severe enough to require them and alternative treatments continue to be inadequate, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
    • Recommending extended release/long acting (ER/LA) opioid pain medicines be reserved for severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine and for which alternative treatment options are inadequate.
    • Adding a new warning about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines.

There was one presentation to the Board: Risk Management for Midomafetamine (David Millis, MD, Clinical Reviewer, Division of Psychiatry; Victoria Sammarco, PharmD, MBA, Risk Management Analyst, Division of Risk Management)

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

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