'Paralyzing Agent' Warning Missing on Neuromuscular Blockers, FDA Says

Megan Brooks

Disclosures

June 05, 2020

The US Food and Drug Administration (FDA) is notifying healthcare providers about the temporary absence of the words "paralyzing agent" 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). 

The "paralyzing agent" warning statement embossed on the vial cap is required on these neuromuscular blocking agents to help clinicians clearly identify that they cause muscle paralysis, and can cause significant patient harm, including death, when used in incorrectly.

During the COVID-19 pandemic, there has been an increased use of vecuronium bromide for injection and rocuronium bromide injection in patients who need mechanical ventilation.

The pandemic has also led to disruptions in supply chains fueling a shortage of product components, such as embossed vial caps, used in manufacturing the container closure for these products, the FDA says

Without the "paralyzing agent" warning, the vial may look like another medication when stored upright in a cabinet drawer or on a shelf next to each other. 

The following products are affected.

Rocuronium bromide injection by Gland Pharma Limited and Mylan Institutional LLC:

  • 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 Limited and distributed by Fresenius Kabi:

  • NDC 63323-781-21

  • NDC 63323-782-23

For now, as a temporary measure meant to increase supply of these drugs, the agency will allow the distribution of vecuronium bromide for injection and rocuronium bromide injection without the "paralyzing agent" statement on the vial cap.

The FDA recommends careful handling of these neuromuscular blocking agents to prevent medication errors that could result in serious harm or death. Specifically, the agency recommends healthcare providers consider the following steps:

  • Add an auxiliary warning label on the vial caps to help alert healthcare providers that the product is a neuromuscular blocking agent.

  • Avoid storing the product so that only the cap is visible.

  • Use 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 the product is stored in automated dispensing cabinets, consider hospital protocols to limit access and manage override removals.

Adverse reactions or quality problems related to this issue should be reported to the FDA's MedWatch program.

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