FDA Investigates Two Adverse Events Associated with United Pharmacy's Compounded Glutamine, Arginine, and Carnitine Product for Injection
The U.S. Food and Drug Administration (FDA) received an adverse event report stating that two patients developed what is described in the report as tissue erosion at the injection site following the administration of an injectable glutamine, arginine, and carnitine (GAC) product that was compounded by United Pharmacy, LLC, located in West Palm Beach, Florida. According to the report, a sample of the product was sent for testing and the pH was determined to be above 11. FDA conducted a for-cause inspection of United Pharmacy and collected samples from two batches of GAC injectable product. Analysis performed on the samples determined the pH to be 10.9, which is alkaline, and no glutamine was detected. Parenteral drugs, including compounded injectable drugs, with a high pH may lead to skin damage or other unintended health consequences.
In an update this week the FDA informed that laboratory analysis found the glutamine in United Pharmacy’s compounded glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
Previously, FDA reported the product was labeled as including 10 mg/mL of glutamine, but no glutamine was found in samples from lots GAC-12 or GAC-13 tested within expiry. Since that time, FDA tested two available samples of the glutamine active pharmaceutical ingredient (API) collected from the API supplier used by United Pharmacy and determined the average purity of the samples to be within the acceptable range at 98.1% and 98.6% of its labeled claim. FDA also further tested the United Pharmacy GAC-12 and GAC-13 samples to determine whether the glutamine degraded.
Glutamine is known to break down to ammonia and pyroglutamic acid in aqueous solutions. FDA laboratory analysis detected the presence of pyroglutamic acid within the samples in amounts roughly equivalent to the degradation of approximately 10 mg/mL of glutamine. Specifically, FDA laboratory analysis showed that the sample from lot GAC-12 that was expired at the time of testing contained 9.28 mg/mL of pyroglutamic acid, which would be the expected degradant product and concentration from 10.51 mg/mL aqueous solution of glutamine. The sample from lot GAC-13 that was within expiry contained 8.91 mg/mL of pyroglutamic acid, which would be the expected degradant product and concentration from 10.09 mg/mL aqueous solution of glutamine. These data suggest that this formulation of glutamine was chemically unstable before the expiration date was reached.
United Pharmacy recalled all of its GAC 10/100/200 mg/mL for injection products and ceased production of this formulation on December 21, 2017, after FDA notified the compounder of these results.
FDA encourages compounders to perform stability studies for solutions containing glutamine to confirm that the glutamine is not degrading before the product’s specified BUD.
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