An FDA Investigation into Two Serious Adverse Events Associated with ImprimisRx’s Compounded Curcumin Emulsion Product for Injection
Two patients administered infusions of curcumin (a component of the spice turmeric) compounded with polyethylene glycol (PEG) 40 castor oil reportedly experienced immediate hypersensitivity reactions. The PEG 40 castor oil was a component of a curcumin emulsion product compounded by a pharmacy, ImprimisRx, located in Irvine, California. Hypersensitivity reactions to intravenous (IV) products containing polyethylene glycol castor oil have been reported in the literature and are the subject of warnings for a number of FDA-approved drugs.
FDA’s investigation into the adverse events associated with ImprimisRx’s curcumin emulsion product for injectionhighlights some of the risks associated with compounded drugs, particularly those that use non-pharmaceutical grade components and ingredients lacking a USP monograph.
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