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06/05/20 md FDA MedWatch - Two Neuromuscular Blocking Agents: CDER Alert
June 5, 2020

From: "U.S. Food and Drug Administration" <fda@info.fda.gov>
To: "michele durda" <michele.durda@hhsys.org>
Sent: Thursday, June 4, 2020 4:17:19 PM
Subject: FDA MedWatch - Two Neuromuscular Blocking Agents: CDER Alert

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
 
A MedWatch Safety Alert was added to the FDA MedWatch web page. 
 
TOPIC: Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps
 
AUDIENCE: Health Professional, Pharmacy, Risk Manager
 
ISSUE: FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10 mL vials.  
 
As a temporary measure, to increase supply of these drugs, FDA is not objecting to the distribution of vecuronium bromide for injection and rocuronium bromide injection, starting June through September 2020 and June through July 2020, respectively, without the embossed “paralyzing agent” warning statement on the vial cap. 
 
The following products are affected:
Rocuronium bromide injection by Gland Pharma and Mylan Institutional:
NDC 68083-364-01 (Gland)
NDC 68083-365-01 (Gland)
NDC 67457-228-05 (Mylan)
NDC 67457-228-10 (Mylan)
 
Vecuronium bromide injection manufactured by Gland Pharma and distributed by Fresenius Kabi:
NDC 63323-781-21
NDC 63323-782-23
BACKGROUND: Vecuronium bromide for injection and rocuronium bromide injection are commonly used to provide muscle relaxation during surgery or mechanical ventilation.  
 
During the COVID- 19 pandemic, there has been an increased use of vecuronium bromide for injection and rocuronium bromide injection in intensive care unit (ICU) patients requiring mechanical ventilation. The COVID-19 pandemic has also caused supply chain disruptions contributing to a shortage of product components, such as embossed vial caps, used in manufacturing the container closure for these products.
 
Currently vecuronium bromide for injection and rocuronium bromide injection include a prominent “Paralyzing Agent” warning statement (in red bold font) on the container labeling which will remain on the vials.  
 
RECOMMENDATION:
The FDA recommends careful handling of these neuromuscular blocking agents as it is vital to prevent medication errors that could result in serious harm or death. 
 
Health care providers should consider the following steps:
  •  Add an auxiliary warning label on the vial caps to help alert health care providers that the product is a neuromuscular blocking agent.
  •  Avoid storing the product so that only the cap is visible. 
  •  Utilize barcode scanning when stocking medication cabinets and preparing or administering the product.
  •  Check the container label to ensure the correct product is being administered.
  • If these products are stored in automated dispensing cabinets, consider hospital protocols to limit access and manage override removals.
Health professionals and patients are encouraged to report adverse events and medication errors related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.






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