FDA Public Health Advisory — Potential Hazards of Skin Products Containing Numbing Ingredients for Relieving Pain from Mammograp
Posted Jan 19 2009 1:16am
FDA is issuing this advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from medical tests and conditions. In February 2007, FDA issued a Public Health Advisory- Life-Threatening Side Effects with the use of Skin Products Containing Numbing Ingredients for Cosmetic Procedures -that described the deaths of two young women who used topical anesthetics prior to laser hair removal [http://www.fda.gov/cder/drug/advisory/topical_anesthetics.htm]. Now, FDA is aware that lidocaine, a type of topical anesthetic, was studied to see if it may reduce discomfort during breast mammography1.
During the study, the topical product was spread over a wide area and covered with plastic wrap. Although no serious side-effects were reported in this study, it was not large enough to evaluate whether uncommon but serious reactions could occur with this use. FDA remains concerned about the potential for topical anesthetics to cause serious and life-threatening adverse effects when applied to a large area of skin or when the area of application is covered.
Topical anesthetics work by blocking pain sensation in the skin. Some of the medication in a topical anesthetic can pass through the skin into the blood stream. More of the medication will pass into the blood stream if the topical anesthetic is applied over a large area of the skin, if a large amount is applied, if it is applied to irritated or broken skin, or if the skin temperature increases. Skin temperature can increase during exercise, by covering the skin with a wrap, or with use of a heating pad. Under these circumstances, the amount of anesthetic medication that reaches the blood stream is unpredictable and may be high enough to cause life-threatening adverse effects such as irregular heartbeat, seizures, breathing difficulties, coma and even death.