Advancing Pediatric Drug Development

Safety of intrathecal hydrocortisone

Briefly describe your research question :

Hydrocortisone has been administered intrathecally (alone or in combination with other agents) to pediatric patients with cancer for decades. The preferred agent is typically the hydrocortisone 100 mg PLAIN (NDC 0009-0825-01).  

However, the following warning is included in the FDA-approved prescribing information: "SOLU-CORTEF Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration."  

Despite decades of the role of hydrocortisone intrathecally, many healthcare institutions/providers (pharmacists, primarily) encounter resistance on a regular basis with internal safety committees and payors about this long-standing practice due to the verbiage in the prescribing information. 

Question: is there sufficient evidence to warrant/support an update to the prescribing information, splitting hydrocortisone plain from the Act-o-Vial and/or modified verbiage regarding the plain product for patients with specific disease states (e.g., leukemia)?

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Idea No. 159