The Food and Drug Administration (FDA) has issued a warning regarding a popular longevity supplement, often called the "master detoxifier," after receiving reports of severe, sepsis-like symptoms in at least 30 individuals. The supplement, dietary-grade glutathione, was administered intravenously and led to hospitalizations for some patients.
Glutathione and Its Popularity
Glutathione is a naturally occurring antioxidant that plays a role in protecting cells from damage. Its levels can decrease with age, stress, poor nutrition, and inadequate rest. Supplementing with glutathione, either orally or intravenously, has become a trend, with proponents claiming it helps combat age-related changes by promoting tissue repair and healthy cell production. Celebrities and influencers have publicly endorsed its use, with some suggesting it may even prevent premature graying of hair.
FDA's Safety Concerns
The FDA's warning, issued recently, specifically addresses compounding pharmacies, reminding them not to use dietary supplement-grade glutathione for injectable products. Compounded drugs are customized medications prepared by pharmacists or physicians to meet specific patient needs. The individuals who became ill received their intravenous glutathione from various compounding pharmacies, but the ingredient originated from Medisca Inc. in Plattsburgh, NY.
While labeled as dietary supplement grade, this type of glutathione is not suitable for injectable drugs because it may contain impurities and contaminants, such as endotoxins, which can be harmful when injected. The FDA noted that ingredients intended for injectable drugs must be appropriate for that use, and dietary supplement ingredients do not meet this standard.
Intravenous administration of glutathione can carry risks, including side effects such as body aches, nausea, headaches, chills, and diarrhea.
Recalls and Ongoing Investigations
Medisca informed the FDA on August 20 that it had alerted its customers against using the dietary supplement in compounded injectables. The FDA has requested compounding pharmacists who received dietary supplement-grade glutathione from Medisca to advise their customers to stop using IV glutathione.
"The FDA is aware of two pharmacies located in Texas that have conducted recalls related to elevated endotoxin levels in their glutathione injectable drugs," the agency stated in its reminder. The FDA continues to investigate adverse events potentially linked to endotoxin exposure and will provide updates as more information becomes available. Despite its trendiness, there is limited scientific evidence to conclusively support the benefits or establish the safety of glutathione supplementation, particularly for intravenous use.