Contaminated Glutathione Injections Sicken Dozens in U.S.

More than 25 people across four states became sick after getting glutathione injections, and at least three were hospitalized, according to the CDC.

All three had received intravenous glutathione, and one had to be admitted to the intensive care unit to be treated for shock and abnormal blood clotting.

The main problem appears to be that all of the injections were made by compounding pharmacies that used glutathione ingredients that were intended for use only in dietary supplements.

CDC emphasized that dietary supplement-grade glutathione “should not be used in sterile injectable drugs because of the risk of introducing contaminants, such as endotoxins.”

The compound is typically sold as a dietary supplement taken by mouth, for promoted purposes such as skin brightening, immune support, detoxification, and increased energy, the agency said.

The outbreak has been simmering since July, when the Texas state health department notified CDC about a group of people who fell ill after getting intravenous glutathione at an outpatient wellness clinic. Since that time, CDC received more reports of similar illnesses from three other states: Washington, Florida, and New York.

At least three pharmacies in Texas have recalled compounded injectable glutathione products because of high levels of endotoxins, and the FDA issued a safety alert reminding compounders not to use dietary supplement-grade glutathione in injectable products. There are no FDA-approved glutathione products currently on the market.

All of the pharmacies got their glutathione from Medisca, headquartered in Plattsburgh, New York, and it was labeled as dietary supplement grade, the FDA said.

The first recall notification from FDA came on Aug. 5, when Victory Medical Center Pharmacy, based in Austin, Texas, recalled certain lots of 200-mg/mL multidose vials of compounded glutathione due to elevated bacterial endotoxin levels.

About 2 weeks later, Optimal Balance Pharmacy in Houston recalled one lot of 200-mg/mL multidose vials of compounded glutathione over elevated bacterial endotoxin levels. This notice said the product had been distributed in other states beyond the four where cases were reported, including Arizona, Colorado, Illinois, Louisiana, Michigan, Nevada, Oklahoma, Pennsylvania, Utah, and Vermont.

The latest recall posted by FDA came late last week, when Centric Compounding of Houston recalled six lots of glutathione 200-mg/mL multidose vials along with injectable products called Myer’s Cocktail and Tri-Immune Boost, also for endotoxin contamination. It said the products were distributed nationwide via home delivery and to prescribers.

The CDC also noted that glutathione injections contaminated with endotoxins were the likely culprit of infections in the past — including a 2015 outbreak in Australia and adverse events at a U.S. clinic that led to an FDA safety alert in 2019.

Symptoms of endotoxin infection include fever, chills, myalgia, headache, nausea, vomiting, and hypotension.

Alex Sundermann, DrPH, of the University of Pittsburgh, said in an Instagram post that it’s likely the case count will rise.

“It’s another reminder not to inject anything into your body that isn’t FDA approved for injection, no matter what claims are being made about it,” Sundermann said.