A 6-year-old patient received three extra doses of two chemotherapies in late 2022, and the FDA sent Children's Hospital of Michigan a warning letter about the mistake.
The patient was part of a now-expired drug trial, according to the letter. During weeks 53, 57 and 61 of the study, extra doses of vincristine and dexamethasone were administered. The hospital said it notified the institutional review board, but the FDA said the Detroit-based hospital's corrective action plan was inadequate.
The hospital told the FDA "these additional treatments occurred because a physician subinvestigator misinterpreted the drug administration plan," according to the letter, which was published Jan. 9.
In response to the error, the Children's Hospital of Michigan said the extra doses were unlikely to increase a safety risk, but the FDA said the patient faced an increased risk of serious toxicities. Excess doses of vincristine, a chemotherapy indicated for lymphoma and leukemia, can lead to neurologic and hematologic toxicities, the letter said.
IRB approval also lapsed for 10 days in January 2022, during which the study drug was administered to a patient, and bone marrow and peripheral blood specimen samples were collected.
The hospital said staff turnover and a delayed continuing review caused the interruption, and its corrective plan is to email reminders 90, 60 and 30 days before the study's approval expires, according to the letter. The agency, however, said the shared plans lack detail on this new policy.
"Without this information, we are unable to determine if your corrective action plan is adequate to prevent similar violations in the future," the FDA said.
Becker's has reached out to the hospital to inquire what trial the patient was involved in, the status of the patient and if it has a response to the FDA's letter. The article will be updated if more information becomes available.