Amidst a resurgence of COVID-19 cases across the United States, pharmaceutical company Gilead Sciences, Inc. has announced a voluntary recall of its antiviral drug Veklury, commonly known as remdesivir, in cooperation with the U.S. Food & Drug Administration (FDA).
The recall comes after the discovery of glass particles in vials of the medication, raising concerns about patient safety at a time when the drug's importance in treating severe COVID-19 cases is once again being underscored.
The affected lot, identified as 47035CFA, was distributed nationwide in the United States beginning July 16, 2024. This FDA-monitored recall coincides with data from the U.S. Centers for Disease Control and Prevention (CDC) showing high levels of COVID-19 viral activity in wastewater across the country, despite a recent decrease in positive cases.
As of September 13, the CDC reports that while overall viral activity in wastewater has been demoted from "very high" to "high," 21 states still show "very high" levels, particularly in the West. Sixteen states exhibit "high" levels, eight are classed as "moderate," and only Michigan and Rhode Island show "low" levels. New York stands out with "minimal" levels, the lowest classification.
The recall of Veklury comes at a critical juncture in the pandemic's trajectory. While positive tests now account for 14.9 percent of all COVID tests (excluding at-home testing) in the U.S., down 1.6 percent from the previous week, the emergence of new subvariants has kept health officials on high alert.
According to Gilead's risk statement, the administration of Veklury which contains glass particles could lead to a range of complications, from local irritation to potentially life-threatening situations if particles enter the bloodstream and cause blockages in vital organs.
Veklury has been a key tool in treating COVID-19 since its FDA approval in October 2020. It is indicated for use in both hospitalized patients and those with mild-to-moderate COVID-19 who are at high risk for disease progression.
The recall affects the lyophilized form of Veklury in single-dose clear glass vials containing 100 mg of remdesivir in powder form. Gilead has reported no adverse events related to this recall to date but is taking proactive measures to mitigate risks.
This recall also comes as the U.S. grapples with a new class of COVID-19 subvariants nicknamed FLiRT. As of August 31, the dominant subvariant, KP.3.1.1, accounted for more than 50 percent of all U.S. COVID-19 cases over the previous two weeks, with FLiRT variants collectively responsible for over 80 percent of cases.
While these new variants appear more infectious, they generally do not cause such severe symptoms. However, the CDC continues to monitor for common symptoms including fever, cough, shortness of breath, fatigue, and loss of taste or smell.
Healthcare facilities possessing the recalled Veklury are urged to cease use immediately and return the product. Gilead has established a dedicated information line at 1-866-633-4474 for those seeking details about the recall.
Patients with concerns about their COVID-19 treatment are advised to consult their healthcare providers, and any adverse reactions can be reported to the FDA's MedWatch Adverse Event Reporting program.