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.  Some must be prescribed by a doctor; others may be purchased without a prescription.  Applying topical anesthetics for a medical procedure is usually done in a doctor’s office by a trained medical professional.  However, FDA is aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals.  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 are sometimes used in ways not approved by FDA and at doses that may pose a risk for serious harm to consumers.   FDA is aware of two instances where women, aged 22 and 25 years old, applied topical anesthetics to their legs to lessen the pain of laser hair removal.  These women then wrapped their legs in plastic wrap, as they were instructed, to increase the creams’ numbing effect.  Both women had seizures, fell into comas, and subsequently died from the toxic effects of the anesthetic drugs.  The skin numbing creams used in these two cases were made in pharmacies and contained high amounts of the anesthetic drugs lidocaine and tetracaine.  FDA also has received reports of serious and life-threatening side effects such as irregular heart beat, seizures and coma, and slowed or stopped breathing following the use of these numbing products.  These effects happened in both children and adults and when the anesthetic drug was used both for approved and unapproved conditions.

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.  The amount of the drug that can pass through the skin and enter the blood also can differ from person to person.

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.

Date created: February 6, 2007, updated February 9, 2007