In an article published today on FDA’s webpage (here), the FDA notes that it “is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients”.
The problem has been identified as the use of a dietary grade of glutathione in the preparation of a parenteral product. Apparently, inclusion of this dietary grade ingredient has led two pharmacies to initiate “recalls related to elevated endotoxin levels in their glutathione injectable drugs”.
“Reported adverse events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, with some resulting in hospitalizations. These symptoms are consistent with exposure to excessive endotoxin levels.” It is imperative that compounding pharmacies (regardless of whether they are 503A or 503B compounders) ensure that they utilize only the appropriate grade ingredients for the preparation of parenteral injectables or other sterile products to prevent such situations from occurring.
The company that supplied the dietary grade material has warned customers that the material is not appropriate for such use. The FDA is continuing its investigation and will provide updates when additional information becomes available.
Compounders need to be aware of the grade of ingredients they are using and ensure that the products they are compounding are “manufactured under conditions and specifications appropriate for the intended route of administration”. The FDA notes that it has previously warned compounders about this very problem on June 7, 2019 (see previous warning here). Compounders must be vigilant in the selection of their choice of ingredients. In the article, the FDA provides suggestions for healthcare professionals, API and inactive ingredient suppliers as well as compounders that receive, evaluate and utilize compounding components prior to use.
