The concern over the glutathione-L reduction powder reduces the FDA's warnings for compounds

The FDA advises pharmacists not to make sterile injectable drugs for patients using reduced glutathione-L powder, distributed by Letco Medical, Decatur, Alabama. According to the reports of adverse events, the agency worries about the use of this product for compound injecting drugs, because of the endotoxin potential.

One patient was hospitalized immediately after receiving an intravenous injection of glutathione 200 mg / mL and 6 other patients would have had various side effects ranging from nausea and vomiting to difficulty breathing. According to the FDA, high levels of endotoxins may have contributed to these adverse events.

Based on this information, the FDA has received various third-party test results on endotoxin levels that may be present in Letco glutathione powder. Further investigation is underway.

Letco supplied this glutathione powder to about 100 preparers in 30 states. Glutathione is reconditioned in 5 sizes – 25g, 50g, 100g, 500g and 1kg – and spread over 13 lots with an expiry date of 17/06/2020. A complete list of lot numbers can be found on the FDA website.

The FDA urges manufacturers who use glutathione to make sterile injectable drugs to ensure that glutathione powder is appropriate for the preparation of sterile drugs, including by checking with their supplier.

Healthcare professionals should check with their authors the source of glutathione used to make sterile drugs for their patients. Patients who have concerns should talk with their health care professionals.

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Reference

FDA warns manufacturers against the use of Letco Medical glutathione for the preparation of sterile drugs [news release]. Silver Spring, MD; February 1, 2019: FDA website. http://www.pharmacytimes.com/link/252. Accessed February 1, 2019.