Regulatory History and Safety of Quinacrine HCl

2021 FDA Science Forum

• Authors: Rocchio, Robert, FDA/CDER; Kneeream, Emily, FDA/CDER; Shetty, Daiva, FDA/CDER; Harrouk, Wafa, FDA/CDER; Johnson, Sue, FDA/CDER; Ganley, Charles, FDA/CDER

• Center: Center for Drug Evaluation and Research

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Abstract

Quinacrine HCl is an unapproved drug historically used in the treatment of malaria. It was nominated to the 503A Bulks List, established under Section 503A of the Food Drug and Cosmetic Act, for pharmaceutical compounding. Bulk drug substances added to this list may be compounded by section 503A compounding facilities. Nominators argued that quinacrine HCl met a clinical need for patients with discoid lupus, which was unmet by other FDA-approved drug products. While there is supportive evidence for its efficacy in meeting the clinical need, quinacrine HCl also poses significant safety risks. 

This presentation summarizes the regulatory history of quinacrine, reviews published literature regarding its safety, in addition to compiling safety data designed to convey relevant risks to public stakeholders. Clinical decision making involved in selecting the most pertinent safety information will also be discussed.  The goal of this presentation is to empower the public by providing knowledge on quinacrine’s safety profile and to illustrate difficulties that the FDA faces when evaluating bulk drug substance nominations.

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