CDC probes cluster of illnesses after glutathione injections linked to dietary-grade product

# What happened Health authorities are investigating a cluster of more than 25 illnesses across four states tied to injectable glutathione. The CDC announced the investigation after reports of acute reactions following injections that used dietary supplement–grade glutathione rather than pharmaceutical-grade material.

# Why the distinction matters The FDA has stated that dietary supplement–grade glutathione "is not an appropriate ingredient to make injectable drugs." Dietary supplement–grade substances are not manufactured or tested to the same standards required for sterile, injectable pharmaceuticals. In this cluster, the FDA reports symptoms consistent with exposure to excessive endotoxin levels, which can occur when sterile injectable products are contaminated with bacterial components.

# Reported clinical picture Patients developed fever, chills, pain, dizziness and sepsis-like signs after receiving injections of glutathione alone or combined with other ingredients. The FDA also listed myalgia, headache, nausea, vomiting, hypotension and death as possible outcomes of endotoxin exposure, although not all of those were reported in this cluster. Some affected people were hospitalized.

# Actions taken so far Two compounding pharmacies in Texas recalled injectable glutathione products because testing found elevated endotoxin levels in certain lots. The CDC and FDA have asked clinicians to:

• Verify with compounding pharmacies which grade and source of glutathione were used to make injectable preparations.
• Talk with patients who received injectable glutathione and are concerned about symptoms.
• Report any additional adverse events to public health authorities.

# Context on glutathione use

# What clinicians and patients should do now Clinicians should ask patients about recent injections and the source of the product when encountering unexplained fever, hypotension, or sepsis-like illness. If a compounded injectable is suspected, confirm the compounding pharmacy and lot numbers, and report events to local public health and the FDA. Patients who received glutathione injections and develop symptoms such as fever, severe muscle pain, dizziness, lightheadedness, persistent nausea or signs of low blood pressure should seek immediate medical care.

# Bottom line The ongoing CDC investigation and FDA guidance focus on the safety gap between nonsterile dietary supplement ingredients and the requirements for injectable drugs. Elevated endotoxin in injectable lots appears to explain many of the reported reactions, and recalls have already been issued for affected lots in Texas. Clinicians should verify product sources, monitor for related adverse events, and report new cases so public health authorities can track and contain the problem.