Patients across four states have been poisoned by bacterial toxins after receiving intravenous drips that contained glutathione, federal health agencies say. The outbreak has sickened over 30 people, and authorities traced the illnesses to wellness clinic IV treatments that used glutathione prepared from powders not intended for injection.
The Centers for Disease Control and Prevention and the Food and Drug Administration said the batches were compounded by specialty drug makers using glutathione material graded for oral dietary supplements. That grade is manufactured for products taken by mouth and is not held to the purity and sterility standards required for injectable medicines, the agencies found.
Glutathione is an antioxidant produced naturally in the body and widely sold as an over-the-counter supplement. It is marketed by some sellers for a range of benefits including detoxification, immune support, higher energy, and skin lightening, but clinical evidence to support those claims is scant. Most use is in oral pill form, though some wellness clinics offer glutathione as part of vitamin and supplement IV cocktails.
The agencies linked the bacterial toxin exposures specifically to the way the injectable mixtures were prepared, not to an FDA-approved injectable glutathione product. There are currently no glutathione products approved by the FDA for injection in the United States. The investigations by public health officials focused on compounding procedures that introduced contamination when powders meant for oral use were repackaged into sterile IV formulations.
The cases underline the risk of administering compounded injectable products made from materials intended for oral consumption, and they highlight a persistent gap between popular wellness practices and the standards required for sterile medical preparations. Federal investigators continue to work with clinics and compounding pharmacies to identify affected patients and trace contaminated lots.
