SALT LAKE CITY (AP) - A Salt Lake City pharmacy behind an anesthetic cream that led to the death of an Arizona woman two years ago has been ordered by the U.S. Food and Drug Administration to stop creating and dispensing the compound drug.
An FDA warning letter dated Dec. 4 instructed University Pharmacy to stop selling a Photocaine gel and a progesterone vaginal cream, two drug compounds the administration said are not generally recognized as safe and effective. The pharmacy has 15 days to respond to the letter.
University Pharmacy owner Richard Rasmuson disagreed with the FDA's statements of the two drug compounds. He said the administration wants to eliminate drug compounding despite court decisions supporting the practice. The FDA does not regulate compounding pharmacies, which are not required to report adverse effects of their drugs.
"They want all compounding to stop and they are trying everything they can to make it stop," he said.
University Pharmacy is one of five firms the FDA is targeting for selling compound anesthetic creams, which are used alleviate pain from procedures such as laser hair removal, tattoos and skin treatments.
The FDA says the compound creams are more concentrated than other products it has approved, and lacks appropriate warnings or directions for use. The creams contain high doses of local anesthetics including lidocaine, tetracaine, benzocaine and prilocaine, and they can be harmful if left on the body for long periods of time or applied to broad areas of the body.
The Utah Division of Occupational and Professional Licensing is reviewing the case of Blanco Bolanos, of Tucson, Ariz. who died after using the Photocaine gel made by University Pharmacy.
Posted in State-and-regional on Sunday, December 10, 2006 12:00 am
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