The quest for longevity is leaving some in worse shape than when they started.
The FDA has issued a warning about a trendy supplement nicknamed the “master detoxifier” after receiving reports that it triggered scary sepsis-like symptoms in some people.
At least 30 patients experienced side effects like fever, chills, pain, dizziness and signs of shock — with some requiring hospitalizing — after receiving dietary-grade glutathione via IV.
This warning comes after a previous one in 2019 about the use of dietary glutathione in compounding injectables.
What is glutathione?
Glutathione is a naturally occurring antioxidant that helps protect cells from damage caused by harmful molecules in the body. Levels can decline due to natural aging, stress, nutrition and improper rest.
It’s become trendy to supplement glutathione — both orally and via IV — with fans saying that it helps combat age-related changes by stimulating the repair of damaged tissue and promoting the production of new, healthy cells. (Gwyneth Paltrow is among the celebrities who like it).
Some experts say it may even stop your hair from graying prematurely.
The risk
The FDA’s warning, issued last week, specifically called out compounding pharmacies, reminding them “not to use dietary supplement grade glutathione for injectables.”
Compounded drugs are customized medications consisting of combined or altered ingredients and created by a pharmacist or doctor to fit individual medical needs.
The 30+ patients who were sickened got their intravenous glutathione through different compounding pharmacies — but they ingredient came from Medisca Inc. in Plattsburgh, NY.
While the glutathione was labeled as dietary supplement grade, it’s not an appropriate ingredient to make injectable drugs with, as these ingredients may contain impurities and contaminants, including endotoxins, that may be harmful when administered as an injectable drug.
IV-administered glutathione can come with nasty side effects like body aches, nausea, headaches, chills and diarrhea.
Medisca informed the FDA on Aug. 20 that it sent customers a warning not to use the dietary supplement in compounded injectables. Meanwhile, the agency has asked compounding pharmacists who received dietary supplement grade glutathione from Medisca to instruct customers to discontinue use of IV glutathione.
“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 wrote in its reminder last week.
The FDA warns that all ingredients used in injectable drugs should be appropriate for their intended use and dietary supplement grade ingredients shouldn’t be used in injectable compounded drugs.
Despite its trendiness, there isn’t much evidence to support its benefits — or determine its safety.
The popular supplement could also do more harm than good, according to one expert.
“Some research suggests that glutathione supplementation can actually shorten lifespan in worms,” Dr. Andrew Steele, a computational biologist, told the Daily Mail. “While the science here is interesting, I think I’d hold off the glutathione for now.”
The FDA is continuing to receive reports of and investigate adverse events consistent with endotoxin exposure, and will provide updates as additional information becomes available.
