Alerts

FDA ALERT

February 7, 2007
Subject: FDA MedWatch: Use of Skin Products Containing Numbing Ingredients (Topical Anesthetic Drugs) for Cosmetic Procedures and Potential Life-Threatening Side Effects
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
FDA informed consumers and healthcare professionals of the potential hazards of using skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning and itching due to a variety of medical conditions. FDA has approved many of these products for these uses. Some of these products must be prescribed by a doctor, others may be purchased without a prescription.
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 the numbing product to their skin, which can cause life-threatening side effects and death. If a skin numbing product is prescribed or recommended for a procedure, consumers should do the following:

– use a topical anesthetic approved by the FDA.
– use a topical anesthetic that contains the lowest amount of anesthetic
drugs possible that will relieve pain.
– ask for instructions from your doctor on how to safely use the topical
anesthetic.
Read the complete MedWatch 2007 Safety summary, including the link to the FDA's Public Health Advisory regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Anesthetics

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