News & Observer | newsobserver.com | Berg's case like one in Arizona

Published: Feb 05, 2005 12:30 AM
Modified: Oct 23, 2005 12:51 PM

Berg's case like one in Arizona

Deaths follow use of numbing cream

Shiri Berg, left, an N.C. State student, and Blanca Bolanos, a student in Tucson, Ariz., both died after using a custom-made pain cream.

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The death of an N.C. State student who applied a prescription-strength numbing cream before laser hair removal is not an isolated case. An Arizona woman died last fall in a strikingly similar way.

Blanca Bolanos, a 25-year-old community college student who lived in Tucson, died Nov. 1 after being hooked to a respirator in her mother's house for nearly two years.

On Jan. 25, 2002, Bolanos applied anesthetic cream to her legs and wrapped them in cellophane several hours before an appointment for laser hair removal. She became disoriented while driving, had seizures and fell into a coma. She never regained consciousness and died of respiratory failure.

NCSU student Shiri Berg, 22, died Jan. 5 under almost identical circumstances.

Their deaths raise questions about the use of untested topical solutions made by compounding pharmacies and widely used by laser hair removal clinics.

It is unknown how many such cases there have been, since the U.S. Food and Drug Administration does not regulate compounding pharmacies, and those pharmacies are not required to report adverse effects of their drugs.

At issue is why the women were given the prescription-strength cream to use outside the clinic, why there were no instructions with the cream or information about side effects, and why the hair removal was scheduled to be done without a doctor present, as lawyers for both women contend.

No prescription

The wide use of compounded creams is at issue, too. Compounders, which make custom drugs in small quantities, operate in a regulatory vacuum. And state pharmacy boards, which are supposed to oversee compounders, rarely have the resources to do so.

Spokesmen for pharmacy boards in Arizona and Utah, where the cream Bolanos used was made, said they never heard of her case.

Neither Bolanos nor Berg had prescriptions for the cream, which was given to them by nonmedical employees at the clinics where they were to have laser hair removal done.

"A lot of these clinics are a cattle call," said Martin Rodriguez, an Arizona lawyer hired by Bolanos' mother. "They want to get people in and out. They don't take the time to do a full history or to make sure the patient is observed. To me, it's reckless."

Rodriguez has filed a lawsuit against the clinic, Golden West Medical Center in Tucson, and Dr. Donald Kwasman, the clinic's physician, alleging wrongful death and medical negligence. Rodriguez has already arrived at an undisclosed out-of-court settlement with the compounder, University Pharmacy of Salt Lake City.

Kwasman could not be reached for comment.

The Bolanos case, which is expected to go to trial in Arizona in August, involves the use of a cream made up of 6 percent lidocaine and 6 percent tetracaine -- a weaker solution than that used by Berg, which had 10 percent lidocaine and 10 percent tetracaine.

Lidocaine is available over the counter at up to 5 percent strength. It is not available in conjunction with tetracaine except through compounding pharmacies.

Rodriguez said a technician at Golden West Medical Center squeezed the cream -- registered under the trademark name "Photocaine" -- from a tube into a condiment-size plastic container. The technician then gave it to Bolanos to use from her groin to her ankles without any written instructions or oral warnings.

"The technician had no education at all with regard to the Photocaine," Rodriguez said. "They did not know it had potential side effects. For all they knew it was Oil of Olay or Jergens."

On the day of her next appointment, Bolanos, who was born in El Salvador, applied the cream to her legs. She then went to see a dermatologist who was treating her for acne. Rodriguez said the dermatologist wrote her a prescription for antibiotics but did no other treatment.


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Staff writer Yonat Shimron can be reached at 829-4891 or yonat.shimron@newsobserver.com.
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