The Food and Drug Administration is investigating reports of adverse reactions consistent with endotoxin exposure in at least 30 patients linked to compounded IV glutathione products. The glutathione was labeled as dietary supplement-grade, which is not appropriate in compounding injectable drugs. It was compounded by different pharmacies, all obtaining their glutathione (Lot #229536) from Medisca Inc. The agency is urging compounders to immediately discontinue use of dietary supplement-grade glutathione in sterile injectables and to notify affected customers.
Reported patient reactions included fever, chills, dizziness, pain, shock, and sepsis-like symptoms, with some patients requiring hospitalization. Two Texas pharmacies have already recalled glutathione injectable products due to elevated endotoxin levels. Medisca told the FDA that it had sent warnings to its customers on Aug. 20 not to use the glutathione in question.
The FDA encourages consumers, health care professionals, and compounders to report adverse events or quality problems experienced with the use of compounded drugs to its MedWatch Adverse Event Reporting program:
- Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program, or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The alert serves as a reminder for compounders to closely vet API and excipient suppliers, ensure ingredients are suitable for the intended route of administration, and build quality into every step of the compounding process rather than relying on end-product testing alone. The FDA previously raised similar concerns about injectable glutathione in 2019. It emphasized that ingredients intended for dietary supplements are not appropriate for injectable drug preparation and may contain harmful contaminants.
Read the full alert here.
