Medication Adverse Event Alert

February 7, 2007

ISSUE:	Life-Threatening Side Effects with the Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures
MEDICATIONS:	Medications that contain topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel.

The following was excerpted from an FDA Med Watch alert dated February 6, 2007:

"FDA is issuing this advisory to alert you to the potential hazards of using skin numbing products, also known as topical anesthetics, for cosmetic procedures. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. 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. FDA has approved many products for these uses. Applying topical anesthetics for a medical procedure is usually done in a doctor's office by a trained medical professional. Without this supervision, a patient may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.

Topical anesthetics work by blocking pain sensation in the skin. Some of the anesthetic drugs in these products can pass through the skin into the blood stream, and if too much gets into the blood, patients can experience serious harm. More drug passes into the blood stream when the product is applied over a large area of skin, when it stays on the skin for a long time, and when the skin is covered after application of the cream. Anesthetic drugs may also pass into the blood stream if the skin is irritated or has a rash, or if the skin temperature goes up. Exercise, covering the skin with a wrap, or use of a heating pad can all increase the skin temperature.

If you are thinking about having a cosmetic or medical procedure on your skin, you should discuss with your doctor if you need a numbing product to ease the pain and, if so, if you can use a topical anesthetic approved for that use by the FDA. You should also discuss with your doctor whether there are other ways to reduce the pain you may feel during the procedure. Some patients report that they do not need to use topical anesthetics. Some procedures may require a degree of numbness that cannot be safely achieved with these products. There are other techniques that doctors can use if a high amount of numbness is needed.

If a topical anesthetic is prescribed or recommended for a procedure and you choose to use one, consider the following:

• 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.