ISMP Report Indicates Some Paralyzing Agent Drugs, Crucial During the Ongoing Pandemic, Lack Adequate Warning Labels

Drug regulators and medical safety experts warn that amid the rush to get treatments for the ongoing COVID-19 pandemic, some drugs that work as paralyzing agents may be missing important safety warnings.

On June 3, the FDA issued an alert to healthcare professionals, indicating that some rocuronium bromide and vecuronium bromide injections were missing labels on the vial caps warning that they were paralyzing agents.

The Institute of Safe Medication Practices (ISMP) is now a warning that the missing labels are a sign of a potentially much larger problem, caused by the rush to produce drugs to treat coronavirus infections.

In addition to the missing labels on neuromuscular blocking agents, the ISMP also indicates that health care professionals may be unaware that a new propofol product, Propoven, contains twice the concentration of the active pharmaceutical ingredient than previous formulations, which could result in accidental overdoses due to medication errors.

“The Institute for Safe Medication Practices (ISMP) is alerting the healthcare community about potential safety issues with critical care drug products being introduced in the U.S. to ease shortages due to the COVID-19 pandemic,” the ISMP stated in a press release issued June 5. “Practitioners should be prepared to take extra precautions with vials of neuromuscular blocking agents without the usual “Warning: Paralyzing Agent” statement required on vial caps and a propofol product that has double the concentration of what is available in the U.S.”

In the case of the neuromuscular blocking agents, rocuronium bromide and vecuronium bromide, the FDA has allowed them to be temporarily manufactured without the warning label on the vial cap, despite the fact that they are considered high risk drugs linked to an increased risk of serious injuries or deaths.

According to the ISMP, the threat is heighted because they may be stocked in locations outside of operating areas and intensive care units, and called for health care organizations to affix auxiliary labels to the vials, warning that they are paralyzing agents.

In the case of Propoven 2%, it is a drug given emergency use authorization, for sedating patients requiring ventilator care during the pandemic. However, it has double the concentration of propofol, the active ingredient, than health care professionals may be used to administering, which could result in accidental drug overdoses.

The ISMP report calls for a careful review of Propoven 2%, and recommended all critical care prescribers, nurses working in critical care units, and anesthesia specialists be alerted to the higher concentration. The group also called for warning stickers to be placed on the drug’s packaging as soon as it is received by the pharmacy and for updates to be made to electronic drug databases.