The U.S. Food and Drug Administration (FDA) has issued a public health advisory concerning the safety of topical anesthetics used to numb the skin. The anesthetics are used in a variety of applications, including on the surface of the breast to decrease discomfort during mammography.
The FDA said that topical anesthetics such as lidocaine, tetracaine, benzocaine, and prilocaine in creams, ointments, or gels can be absorbed into the bloodstream when applied to the surface of the skin. If used improperly, they "may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma, or even death," according to the advisory. The FDA said that it has received reports of adverse events and the deaths of two women who used topical anesthetics before laser hair removal.
In announcing the advisory, the FDA cited a recent study in Radiology that examined two ways of decreasing discomfort during mammography -- one method in which women took acetaminophen and ibuprofen by mouth and another in which lidocaine gel was applied to a wide surface area of the skin and then covered in a plastic wrap. The FDA said that there were no side effects reported in the study, but the agency is concerned about potential health effects given the experience with topical anesthetics and laser hair removal.
The FDA is advising patients to talk with their healthcare professional if they are considering using a topical anesthetic before a mammogram. The FDA also advises that patients do the following:
- Use a topical anesthetic that contains the lowest strength and 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.
- Do not apply the topical anesthetic to broken or irritated skin.
- Ask their healthcare professional what side effects are possible and how to lower their chance of having life-threatening side effects from anesthetic drugs.
- Be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present.
Information on the alert is available by clicking here.
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