Faced with a resurgence of COVID-19 cases in 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 follows the discovery of glass particles in vials of the drug, raising concerns about patient safety at a time when the drug’s importance in treating severe cases of COVID-19 is once again being highlighted.
The affected lot, identified as 47035CFA, was distributed nationwide 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 decline in positive cases.
On September 13, the CDC reported that while overall viral activity in wastewater has increased from “very high” to “high,” 21 states still have “very high” levels, particularly in the West. Sixteen states have “high” levels, eight are classified as “moderate,” and only Michigan and Rhode Island have “low” levels. New York stands out with “minimal” levels, the lowest classification.
The Veklury recall comes at a critical time in the pandemic’s trajectory. While positive tests now account for 14.9% of all COVID tests (excluding at-home tests) in the United States, down 1.6% from the previous week, the emergence of new subvariants has kept health officials on high alert.
According to Gilead’s risk statement, administration of Veklury, which contains glass particles, could lead to a range of complications, from local irritation to life-threatening situations if the particles enter the bloodstream and cause blockages in vital organs.
Veklury has been a key tool in the treatment of COVID-19 since its FDA approval in October 2020. It is indicated for use in hospitalized patients and in people with mild to moderate COVID-19 who are at high risk of disease progression.
The recall involves the lyophilized form of Veklury in single-dose clear glass vials containing 100 mg of remdesivir as a powder. Gilead has not reported any adverse events related to this recall to date, but is taking proactive steps to mitigate risks.
The reminder comes as the United States grapples with a new class of COVID-19 subvariants dubbed FLiRT. As of August 31, the dominant subvariant, KP.3.1.1, accounted for more than 50% of all COVID-19 cases in the United States over the previous two weeks, with FLiRT variants collectively responsible for more than 80% of cases.
While these new variants appear to be more contagious, they generally do not cause as 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 that have the recalled Veklury product are urged to immediately stop using it and return it. Gilead has set up a dedicated information line at 1-866-633-4474 for individuals wishing to obtain information about the recall.
Patients with concerns about their COVID-19 treatment are advised to consult with their healthcare providers and any adverse reactions can be reported to the FDA’s MedWatch Adverse Event Reporting Program.
