Details
The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) received an inquiry from another Federal partner requesting information on the impact of the 2023 shortage of injectable methotrexate products on methotrexate utilization, specifically on use among pediatric patients with cancer. FDA conducted this rapid Sentinel study to estimate the utilization of injectable methotrexate among pediatric and adult patients, with and without cancer diagnoses.
The findings from this study showed declines in injectable methotrexate use after shortages were declared, most notably in adult patients without evidence of cancer diagnosis. Among pediatric patients with evidence of cancer diagnosis, injectable methotrexate use appeared relatively steady over time. There was a slight steady decline in use among pediatric patients without evidence of cancer after the shortage was declared. This assessment provided FDA and interested parties insight into the impact of methotrexate injection shortages on patient utilization, specifically for pediatric patients with cancer.