Two years after an Arizona woman died from a controversial numbing cream, the U.S. Food and Drug Administration has ordered the Salt Lake City pharmacy that created and dispensed the drug to stop.

In a warning letter dated Dec. 4, the FDA told University Pharmacy to stop selling two drug "compounds," a Photocaine gel and a progesterone vaginal cream, saying the compounds are not generally recognized among experts as safe and effective.

To date, the Utah Division of Occupational and Professional Licensing has not taken any public action against University Pharmacy in regard to the 2004 death of Blanco Bolanos of Tucson. But as a result of the FDA's warning, the state is reviewing the case, said Department of Commerce spokeswoman Jennifer Bolton.

If the division decides to take action, University Pharmacy may face any one or a combination of the following: a letter of warning, fines, probation or have its license revoked.

The pharmacy, located at 1320 E. 200 South, is one of five firms targeted by the FDA for selling topical anesthetic creams used to lessen pain in procedures such as laser hair removal, tattoos and skin treatments.

The FDA says such creams are more concentrated than FDA-approved products, and often lacking appropriate warnings or directions for use. It also classifies such compounds as new drugs.

Richard Rasmuson, owner of University Pharmacy, said he would not treat the FDA warning "lightly," but he disputed that that the compounds identified in the FDA letter are misbranded or unsafe. He claimed the FDA wants to eliminate drug compounding despite court decisions supporting the practice.

"They want all compounding to stop and they are trying everything they can to make it stop," he said.

Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug. The FDA insists the recent action is not targeting that practice. Rather, the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution, according to the FDA.

Compounding pharmacies are not new but the scope of what they are producing has increased dramatically due to accommodate the growth of boutiques for laser surgery, Botox injections and "rejuvenating" procedures.

The creams targeted by the FDA contain high doses of local anesthetics including lidocaine, tetracaine, benzocaine and prilocaine, and are more risky than FDA-approved numbing agents, according to the government. The compounds can be especially harmful if left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic or other dressing.

That's what caused Blanco Bolanos, 25, to lapse into a coma and die, said Martin Rodriguez, a lawyer who represented the woman's family in lawsuits.

In January 2002, Bolanos applied Photocaine, a gel of 6 percent lidocaine and 6 percent tetracaine made by University Pharmacy, to her legs and wrapped them in cellophane prior to laser hair removal at Golden West Medical Center in Tucson. She spent two years tied to a respirator in her mother's home before dying Nov. 1, 2004.

In a phone interview, Rasmuson said he developed the Photocaine gel for a local doctor to use in his laser surgical practice. The doctor liked it so much that he bragged about it at conventions, causing orders to pour in from around the country. Although the drug is only for office use, the onslaught made Rasmuson "a little nervous," he said. "But the doctors calling are capable and talented, and, as a small pharmacy, we don't want to turn away business."

In the Arizona case, Rasmuson said a technician instructed Bolanos to use the cream on too large an area of the skin. Nonetheless, the pharmacy reached a confidential settlement with the Bolanos family, as did the Arizona doctor and the medical center.

Those deals did nothing to solve the bigger problem, Rodriguez said. "Blanco died and these guys keep marching right along," he said. "I feel sick about it. I did not get done what I set out to accomplish."

A month after Bolanos died, a North Carolina State University senior named Shiri Berg died from an overdose of compounded lidocaine gel applied prior to laser hair removal. Like Bolanos, Berg began having seizures on the way to the clinic, slipped into a coma and later died. The pharmacy that supplied the cream, Triangle Compounding Pharmacy, received a warning letter similar to the one sent to University Pharmacy.

The FDA action is long overdue, Rodriguez said, noting he tried to get the FDA to investigate in 2002.

In the case of University Pharmacy, the initial investigation took place in March 2005.

FDA spokeswoman Susan Cruzan said putting together a case against five pharmacies takes time.

"FDA does have a process and it takes time to determine what is going on," she said. "You've got to document and verify information before sending out a warning letter."

The pharmacies have 15 days to respond.

lfantin@sltrib.com

Stores

under fire

Five pharmacies received FDA warnings this week about compounding topical anesthetic creams. The firms have 15 days to respond. They are:

* University Pharmacy, Salt Lake City

* Triangle Compounding Pharmacy, Cary, N.C.

* Custom Scripts Pharmacy, Tampa, Fla.

* Hal's Compounding Pharmacy, Inc., San Diego.

* New England Compounding Center, Framingham, Mass.