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FDA Drug Safety Podcasts
Transcript [music] On February 6, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures and Life-Threatening Side Effects. I am Mandy Eisemann from FDA's Center for Drug Evaluation and Research. We are 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. We have 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, we are aware that use of these products before a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, patients 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 us and at doses that may pose a risk for serious harm to consumers. We are 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. We also have 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. Patients who are considering a cosmetic or medical procedure on their skin should discuss with their doctor the need for a numbing product to ease the pain and, if so, should use a topical anesthetic approved for that purpose by the FDA. In discussing the use of a topical anesthetic, other ways to reduce the pain during the procedure should be considered between the patient and doctor. 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, patients should consider the following: First: Use a topical anesthetic approved by the FDA. Approval information is available by going to our Web site at F-D-A dot G-O-V slash C-D-E-R and clicking on the link to the Orange Book. Type in the product's active ingredient or name in one of the Orange Book's search fields. If the product is not listed, it may not be approved. Second: Use a topical anesthetic that contains the lowest amount of anesthetic drugs possible to achieve pain relief. 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. Third: 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. For more details, our Web site, F-D-A dot G-O-V slash C-D-E-R, has links to FDA's Press Release and Warning Letters about high-strength unapproved topical anesthetics made by pharmacies. You can also find links to more information on unapproved drugs. We are asking health-care professionals to report serious adverse events in connection with topical anesthetics to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot G-O-V slash MedWatch. Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site F-D-A dot G-O-V slash C-D-E-R. [music] Additional Information
Date created: February 6, 2007 |
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