FDA warns on compounding anesthetic creams

The US Food and Drug Administration is warning five firms - Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal's Compounding Pharmacy and New England Compounding Center - to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients. Firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.

The FDA says it is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats. Two deaths have been connected to compounded products made by Triangle and University Pharmacy, two of the five pharmacies receiving warning letters.

"Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by [the] FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision," said Steven Galson, Director of the agency's Center for Drug Evaluation and Research. The FDA is advising consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.