The FDA issued warnings to 5 pharmacies around thecountry, directing each of them to stop compoundingand distributing standardized versions of topical anestheticcreams.
The compounded creams at issue were being "marketedfor general distribution rather than responding to theunique medical needs of individual patients," said the FDAin justifying the action. The warnings, which include athreat that the compounding pharmacies could faceinjunctions or seizures unless distribution is halted, wereprompted by FDA concerns about health risks associatedwith compounded topical anesthetic creams.
"Exposure to high concentrations of local anesthetics,like those in compounded topical anesthetic creams, cancause grave reactions including seizures and irregularheartbeats," said the agency. According to the agency, 2deaths already have been connected to compounded topicalanesthetic creams made by Triangle CompoundingPharmacy of Cary, NC, and Salt Lake City-based UniversityPharmacy, 2 of the 5 pharmacies receiving warning letters.Other pharmacies receiving warnings were Custom ScriptsPharmacy (Tampa, Fla), Hal's Compounding Pharmacy (SanDiego, Calif), and the New England Compounding Center(Framingham, Mass).
The FDA officials said that similar topical anestheticcreams are being compounded by the other pharmaciesand that the agency's action should serve as a "generalwarning" to those pharmacies as well.