IV Post

Washington, DC - In January 2009, the Food and Drug Administration (FDA) issued a public health advisory about the improper use of skin numbing products. Also known as topical anesthetics, these products have been used to lessen pain in certain procedures such as skin treatments and laser hair removal.

FDA has received reports of adverse events and deaths of two women who used topical anesthetics before laser hair removal.

Available over-the-counter and by prescription, topical anesthetics work by blocking pain sensation in the skin. They contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. These products can be absorbed into the blood stream.

Used improperly, they can cause

• irregular heartbeat
• seizures
• breathing difficulties
• coma
• death

Recent Study

FDA is aware of a recently published study in Radiology that showed women had less discomfort during mammography when they applied lidocaine gel before the procedure than when they used plain gel or took oral acetaminophen or ibuprofen.

There were no serious or life-threatening side effects reported in the study, nor were any reported when FDA discussed the results with the doctor who performed the study.

However, given the small size of the study and the life-threatening side effects associated with the use of topical anesthetics during laser hair removal, FDA is concerned that similar side effects could occur when these products are used before mammography.

Advice for Consumers

If you are considering using a topical anesthetic before a mammogram or any other procedure, you should talk with your health care professional first.

Health care professionals should determine whether adequate pain relief can be safely achieved with a topical anesthetic, or whether a different treatment would be more appropriate.

Here is some advice to follow if a topical anesthetic is recommended for you:

• Ask your health care professional what side effects are possible and how to lower the chance of having life-threatening side effects from anesthetic drugs.
• Use a topical anesthetic containing the lowest strength and the lowest amount of medication that will relieve the pain.
• Apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur.
• Don't apply topical anesthetic products heavily over large areas of skin.
• Don't use formulations that are stronger or more concentrated than necessary.
• Don't apply these products to irritated or broken skin.
• Don't wrap treated skin with plastic wrap or other dressings. Wrapping or covering treated skin with any type of material can increase the chance of serious side effects.
• Don't apply heat from a heating pad to skin treated with these products. When skin temperature increases, the amount of anesthetic reaching the blood stream is unpredictable. The risk of life-threatening side effects increases with greater amounts of lidocaine in the blood.

Report adverse events to FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.