FDA Update: Boxed Warning for Benzodiazepines

On Sep 23, 2020: FDA released this new announcement in their Drug Safety Communication, that the following update will be included in the Boxed Warning for benzodiazepines medication class:

To include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.

FDA Instructions for Health Professionals:

  1. Limit the dosage and duration of benzodiazepines.
  2. During the entire duration of treatment monitor for signs and symptoms of abuse, misuse, or addiction.
  3. Always do gradual taper to prevent the risk of withdrawal. 
  4. Particular caution when benzodiazepines are combined with opioids.

According to FDA, the most common benzodiazepine prescribed in 2019 were:

  1. Alprazolam (38%) followed by
  2. Clonazepam (24%)
  3. Lorazepam (20%)
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WATCH THE FOLLOWING JOURNAL CLUB DISCUSSION:

Journal Club #10:

Association of Benzodiazepines & Z-Drugs with Subsequent Dementia.

Article: Am J Psychiatry. 2020; April 07.

This journal club will answer the following five clinically relevant questions:

  1. Cognitive and Intellectual Impairment with benzodiazepines use in elderly.
  2. Psychomotor Impairment with benzodiazepines use in elderly?
  3. Does (a) Duration of benzodiazepines, (b) Dose, and (c) Long vs short acting benzodiazepine increases the risk of subsequent dementia in elderly?
  4. Do benzodiazepines or Z-drugs increases the risk of subsequent dementia in elderly with affective disorder?
  5. For patients with prior history of benzodiazepine, do addition of Z-drugs influence the risk of dementia?

This journal club includes an expert discussion section with Dr. Rajesh Tampi.

He will answer the following clinically relevant questions:

  1. Should our decision to prescribe benzodiazepines in elderly change after this article?
  2. How long and how much of benzodiazepines can be used in elderly?
  3. When and how can we use benzodiazepines safely in elderly?
  4. How can we educate patients, their family or caregivers regarding the use of benzodiazepines in elderly?
  5. What cautions should a physician be mindful of while prescribing benzodiazepines in elderly?
  6. Which is the preferred benzodiazepine, if used in elderly?
  7. Limitation of studies to assess the risk of dementia with benzodiazepines use in elderly.

Journal Club #10 is Available for Course Subscriber Only:

Psychiatry Education Forum’s Journal Club is a free feature for Physician’s Guide for Clinical Psychiatry course subscribers.

JOURNAL CLUB SCHEDULE:

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of PeerPoint Medical Education Institute, LLC and Psychiatry Education Forum LLC. The PeerPoint Medical Education Institute, LLC is accredited by the ACCME to provide continuing medical education for physicians.

The PeerPoint Medical Education Institute, LLC designates this enduring activity for a maximum of 4.25 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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