An example of this is topical anesthetic creams. These products are often used in spas and medical clinics to lessen pain associated with laser hair removal and skin treatments. Exposures to high concentrations of local anesthetics, like those in the topical anesthetic creams, can cause serious adverse reactions including seizures, irregular heartbeat and death.
For example, the Pharmacy Compounding team received reports of two deaths connected to a compounded topical anesthetic cream. The team found that there were several problems with some of these products. Some contained higher concentrations of the anesthetic than what was present in the FDA-approved product. Many of these compounded products contained multiple combinations of anesthetic products, which produced an additive effect. To add to the problem, these products often lacked appropriate directions for use by consumers and health care professionals. Compounding team sent out several warning letters to pharmacies marketing and distributing these creams, directing them to stop this practice.
source found here at FDA CDER World of Compliance
For example, the Pharmacy Compounding team received reports of two deaths connected to a compounded topical anesthetic cream. The team found that there were several problems with some of these products. Some contained higher concentrations of the anesthetic than what was present in the FDA-approved product. Many of these compounded products contained multiple combinations of anesthetic products, which produced an additive effect. To add to the problem, these products often lacked appropriate directions for use by consumers and health care professionals. Compounding team sent out several warning letters to pharmacies marketing and distributing these creams, directing them to stop this practice.
source found here at FDA CDER World of Compliance
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