Topical Anesthetic Kills Two Women

Beth Janicek
Attorney
(866) 735-1102 Ext 395
Posted by Beth JanicekFebruary 02, 2009 1:13 PM

Two young women were killed after using topical anesthetic to prepare for laser hair removal. The two women applied the topical anesthetic then wrapped their legs in plastic wrap to increase the cream’s numbing effect. Both women had seizures, fell into comas, and died from toxic effects of the anesthetic drugs. The Food and Drug Administration has issued a Public Health Advisory on the potentially serious risks associated with using topical anesthetics for relieving pain, particularly when used for cosmetic procedures.

These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment or gel and can be found in prescription and nonprescription strengths. “Topical anesthetics are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain and burning and itching due to a variety of medical conditions.”

However, when the product is used in large amounts, stays on the skin for a long time, or is covered after application, the medicine can pass through the skin into the bloodstream. The anesthetic drugs can also pass into the blood stream if the skin is irritated or has a rash, or if the skin temperature goes up. If the amount of anesthetic reaches the blood in a high amount, it can cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma, and even death.

The FDA is particularly concerned about the serious public health risks related to compounded topical anesthetic creams and has consequently issued warnings to five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams.

According to Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research,

“Compounded topical anesthetic creams, like compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved.”

Certainly, these companies need to be held accountable for any damages that result from the dangerous creams they produce but the facilities who perform the cosmetic procedures and encourage the use or misuse of these dangerous creams also need to be held accountable.

The FDA warns that if you are thinking about having a cosmetic or medical procedure it is very important to use a topical anesthetic that has been approved for that use by the FDA. The advisory goes on to list different issues that are important to consider before the use of a topical anesthetic, such as:

  • use a topical anesthetic approved by the FDA. Approval information is available by going to http://www.fda.gov/cder/ob/default.htm and typing in the product’s active ingredient or name. If you do not see the product, the product may not be approved.
  • use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that will relieve your pain. Ask your doctor if the amount of anesthetic drugs in the cream is needed or advised for your procedure. There are medical procedures that use skin numbing products with high concentrations of anesthetic drugs. Ask your doctor what side effects are possible from these drugs and how to lower your chance of having life-threatening side effects from these drugs.
  • be sure you receive instructions from your doctor on how to safely use the topical anesthetic. This is especially important if you are having a cosmetic procedure because a doctor may not be present when you use the product. Apply as little of the cream to cover the affected skin area for the briefest period possible. If wrapping or covering the skin with any type of material or dressing is recommended or desired, be aware that this step can increase the chance of side effects.

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