# \[e-drug\] compounded drugs too lightly regulated? (3) **URL:** \ **Category:** e-drug\ **Created:** [February 5, 2005, 1:33pm UTC](https://talk.edrugplus.org/t/e-drug-compounded-drugs-too-lightly-regulated-3/21557 "2005-02-05T13:33:16Z")\ **Posts on this page:** 2\ **Page:** 1
**Author:** ![Sarah\_Sellers1](https://avatars.discourse-cdn.com/v4/letter/s/898d66/32.png) [@Sarah\_Sellers1](https://talk.edrugplus.org/u/Sarah_Sellers1)\ **Post date:** [February 5, 2005, 1:33pm UTC](https://talk.edrugplus.org/t/e-drug-compounded-drugs-too-lightly-regulated-3/21557/1 "2005-02-05T13:33:16Z")
E-DRUG: compounded drugs too lightly regulated? (3) --------------------------------------------------- [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. Copied as fair use. WB] [http://newsobserver.com/news/health\_science/medical\_spas/story/2091561p-8470349c.html](http://newsobserver.com/news/health_science/medical_spas/story/2091561p-8470349c.html) Berg's case like one in Arizona Deaths follow use of numbing cream By YONAT SHIMRON AND MICHAEL EASTERBROOK, Staff Writers 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. When that appointment was over, Bolanos drove toward Golden West Medical Center for her laser hair removal treatment. Halfway there, she called a friend on her cell phone to tell her something was wrong. She was lost and couldn't seem to find her way, Rodriguez said. Bolanos then called her boyfriend with a similar complaint, and he told her to stop and wait for him to pick her up. She pulled into the Pueblo Inn parking lot and began having seizures. Her boyfriend arrived soon afterward, but she was unconscious, Rodriguez said. In an emergency room, physicians found the cellophane on her legs, and secondary burns where she had applied the cream. Physicians called the clinic, but a nurse practitioner on call told them the cream on Bolanos' legs contained no medication, Rodriguez said. Bolanos spent the last two years of life tethered to a respirator at her mother's home. "I was waiting for God to work a miracle," said Denis Rodriguez, Bolanos' mother. "I wanted him to give her back to me." 'She was my right hand' Rodriguez, who is no relation to her lawyer, described her daughter as ambitious and hard-working. In addition to taking classes, she was the office manager of a greyhound race track and waited on tables at her mother's Salvadoran restaurant. "She was my right hand," said Rodriguez, who closed the restaurant to care for her daughter. In North Carolina, the medical and pharmacy boards are investigating the death of Berg, a senior in biochemistry who was planning on attending medical school. The FDA is also investigating. The North Raleigh clinic where Berg was to have laser hair removal, Premier Body on Falls of the Neuse Road, closed Monday. Rodriguez said she was devastated when she learned the exact same thing happened to a woman in North Carolina, and added, "Now another mother is going through what I'm going through." Staff writer Yonat Shimron can be reached at 829-4891 or yonat.shimron@newsobserver.com. ---
**Author:** ![Dr\_J.W.F\_van\_Mil](https://avatars.discourse-cdn.com/v4/letter/d/85e7bf/32.png) [@Dr\_J.W.F\_van\_Mil](https://talk.edrugplus.org/u/Dr_J.W.F_van_Mil)\ **Post date:** [February 6, 2005, 1:15pm UTC](https://talk.edrugplus.org/t/e-drug-compounded-drugs-too-lightly-regulated-3/21557/2 "2005-02-06T13:15:03Z")
E-DRUG: compounded drugs too lightly regulated? (3) --------------------------------------------------- Dear All, After reading the title of the messages, as a pharmacist I am surprised at its content. To me there seems to be nothing wrong in the regulation of the compounded drugs in this case, but in their use and the behaviour of health care staff. In both cases, it was basically irrelevant that the cream was compounded (there seems to be even a registered product with the same ingredients and strength). It was relevant that untrained personell at a clinic had given out cream that obviously could do harm, without sufficient warning or instructions. Pharmacies can dispense for in-house use in clinics, but in my opinion not be held responsible for what staff-members in a clinic then do with this well-prepared cream. That is the responsability of the clinics director and staff. Therefore the title of this e-drug message should IMHO read: 'clinic staff fails to give proper instructions'. Foppe van Mil Foppe van Mil, PhD, Pharm D. Pharmacy practice consultant Margrietlaan 1, NL 9471 CT Zuidlaren, The Netherlands Tel: +31 50 4029095. Fax +31 50 4090732 Email: jwfvmil@planet.nl [Foppe has a point. E-drug moderators try to follow discussions and add numbers for easy follow-up. We could indeed have changed the title. Next time! WB]