Gilead recalls 2 lots of Veklury after investigation confirms complaint of glass particulates
Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.
Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.
Those results have people questioning the drug’s approval, and its cost of $3,000. The FDA gave it full approval in October based on three different studies.
The drug gained emergency use authorization in May 2020, and was famously given to US President Donald Trump when he was battling the coronavirus. Gilead has said that the drug reduced the risk of death by 62% when compared with other standards of care.
The treatment is intended for adults and children above the age of 12 who require hospitalization for Covid-19. The two lots affected by the recall, 2141001-1A and 2141002-1A, were distributed throughout the US in October 2021. They both have expiration dates of January 2024.
If a drug with glass particulate is injected into a patient, side effects could be as simple as redness and swelling at the injection point, to traveling to organs and blocking blood vessels in the heart, lungs or brain. That can lead to stroke and death.
So far, there have been no reports of any events related to the recall, Gilead said. Anyone who has experienced side effects from the shot should reach out to the FDA’s adverse event reporting program online at www.fda.gov/medwatch/report.htm or by calling them at 1-800-332-1088.
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