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FDA warns topical anesthetic creams compounders

Washington — The Food and Drug Administration (FDA) has issued warnings to five firms — Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy and New England Compounding Center — in an effort to stop compounding and distributing standardized versions of topical anesthetic creams.

According to an FDA statement, companies that fail to resolve violations cited in the warning letters risk injunctions against continuing violations and seizure of illegal products.

The statement says the FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, such as those in compounded topical anesthetic creams, can cause serious reactions that include seizures and irregular heartbeat.

Compounded topical anesthetic creams are commonly used to lessen pain in procedures such as laser hair removal, tattoos and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices. FDA-approved topical anesthetic products are commercially available and properly labeled, and are regularly used in health-care settings. However, some pharmacies create their own standardized versions of these products, often including combinations of ingredients that are at higher strengths than those found in FDA-approved products—and that often lack appropriate warnings or usage directions.

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