The pharmaceutical company Gilead Sciences has been forced to conduct a major recall of its antiviral treatment Veklury (remdesivir).
The medicine is used to treat both children and adults with mild to moderate COVID-19 at high risk of developing severe disease. The recall was initiated after a customer reported an anomaly, which led to an internal investigation at Gilead. The investigation confirmed the presence of a glass particle in one of the medicine bottles. The finding has led the company, in consultation with the US Food and Drug Administration (FDA), to recall an entire batch of the drug.
Injecting a medicine containing glass particles can have serious consequences. The glass particles can pass through the blood vessels to different organs and can cause anything from localised irritation and swelling to more serious conditions such as pulmonary embolism, microemboli and granuloma formation in different organs and acute inflammation. In the worst cases, these particles can block blood vessels in vital organs such as the heart, lungs or brain, leading to stroke or even death.
The scope of the revocation
The recall applies specifically to the Veklury lot with lot number 47035CFA, which was distributed across the United States as of 16 July 2024. Gilead is urging all healthcare facilities that have bottles from the affected lot to immediately stop using them and return them according to the company’s instructions. Patients experiencing problems are encouraged to contact their healthcare providers. In addition, adverse events may be reported to the FDA.
The incident highlights a wider issue in the pharmaceutical industry. Glass ampoules, often used for liquid medicines, are a common cause of occupational injury among healthcare workers. There is discussion about training staff on how to safely handle glass ampoules and also whether plastic materials could be used as an alternative, which is complicated by the fact that medicines can react with the plastic.
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