The Food and Drug Administration (FDA) has issued a safety alert regarding the preparation of vinca alkaloids.
According to the Agency, these chemotherapy agents, which include vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection, should only be prepared in intravenous (IV) infusion bags. In order to reduce the potential for unintended intrathecal administration, the FDA is working with manufacturers to update the drug labeling to remove instructions for preparation of these agents by syringe.
The action is in response to data that suggest that dispensing vinca alkaloids in IV bags, rather than in syringes, reduces the risk of erroneous intrathecal administration. While the FDA has previously strengthened warnings related to administration in the prescribing information for vinca alkaloids, the Agency is now moving to remove the instructions related to syringe preparation entirely.
The administration update will be reflected in both the brand and generic versions of these products. Adverse events experienced with the use of vinca alkaloids should be reported to the FDA’s MedWatch Adverse Event Reporting program.
FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. [press release]. Silver Spring, MD; US Food and Drug Administration: January 15, 2021.