Medical spas are under investigation in two states for the deaths of two women who were sold prescription-strength numbing cream without the supervision of a physician. Lawyers for the two families stipulate that the cream was sold to use outside the clinic and that no written instructions or warning about possible side effects were given. Neither woman had prescriptions for the cream, which was given to them by non-medical employees where they were to have laser hair removal done.
The most recent death was in January of this year. Twenty-two year old college senior Shiri Berg died after reacting violently to a compounded 10% lidocaine cream and 10% tetracaine drug, commonly used before laser hair removal. Berg purchased the solution from the medical spa Premier Body during a consultation. A motorist saw Berg unconscious in her car and called an ambulance. She fell into a coma soon after she was admitted to Rex and never regained consciousness. She died Jan. 5 at Rex Healthcare after being unconscious for more than a week.
Berg's death is strikingly similar to the fatal lidocaine overdose of an Arizona coed, who died last November after nearly two years on a respirator. Blanca Bolanos, a 25-year-old college student who lived in Tucson, died Nov. 1 2004 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.
The incident in North Carolina is under investigation by the state pharmacy and medical boards and the Food & Drug Administration. At issue is whether there was a prescription in Berg's name as required, whether the spa's medical director was registered with the board to dispense drugs, and whether the gel was properly dispensed at the spa. Physicians registered with the board may delegate administration of the drug to other personnel, but a doctor must do the dispensing.
Patsy Angelle, president of the International Academy of Compounding Pharmacists, said the problem in the Berg case was not with the compounded medication itself but how it was administered. 'In this case, it appears that the clinic did not give adequate direction to the patient, and a tragedy unfortunately occurred,' she said. Michael Cohen, R.Ph., DSc., president, Institute for Safe Medication Practices, noted that Berg did not get the drug from a retail pharmacy where there could have been counseling about the danger of applying 10% lidocaine over nearly half her body and then putting occlusive wrapping over it. It is a standard practice in medical spas to use cellophane to keep cream from rubbing off on patients' clothes.
Noted laser hair removal authority Dr. David Goldberg agrees that the toxicity resulted from misuse of the product. Goldberg's medical offices dispense numbing cream for take home use before treatments, but only after several visits where the cream is applied in-office.
The most recent death was in January of this year. Twenty-two year old college senior Shiri Berg died after reacting violently to a compounded 10% lidocaine cream and 10% tetracaine drug, commonly used before laser hair removal. Berg purchased the solution from the medical spa Premier Body during a consultation. A motorist saw Berg unconscious in her car and called an ambulance. She fell into a coma soon after she was admitted to Rex and never regained consciousness. She died Jan. 5 at Rex Healthcare after being unconscious for more than a week.
Berg's death is strikingly similar to the fatal lidocaine overdose of an Arizona coed, who died last November after nearly two years on a respirator. Blanca Bolanos, a 25-year-old college student who lived in Tucson, died Nov. 1 2004 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.
The incident in North Carolina is under investigation by the state pharmacy and medical boards and the Food & Drug Administration. At issue is whether there was a prescription in Berg's name as required, whether the spa's medical director was registered with the board to dispense drugs, and whether the gel was properly dispensed at the spa. Physicians registered with the board may delegate administration of the drug to other personnel, but a doctor must do the dispensing.
Patsy Angelle, president of the International Academy of Compounding Pharmacists, said the problem in the Berg case was not with the compounded medication itself but how it was administered. 'In this case, it appears that the clinic did not give adequate direction to the patient, and a tragedy unfortunately occurred,' she said. Michael Cohen, R.Ph., DSc., president, Institute for Safe Medication Practices, noted that Berg did not get the drug from a retail pharmacy where there could have been counseling about the danger of applying 10% lidocaine over nearly half her body and then putting occlusive wrapping over it. It is a standard practice in medical spas to use cellophane to keep cream from rubbing off on patients' clothes.
Noted laser hair removal authority Dr. David Goldberg agrees that the toxicity resulted from misuse of the product. Goldberg's medical offices dispense numbing cream for take home use before treatments, but only after several visits where the cream is applied in-office.