Creams, gels and ointments containing topical anesthetics such as lidocaine, tetracaine, benzocaine and prilocaine can be valuable in relieving or preventing pain. But they can be dangerous when used by patients without medical supervision.
FDA is aware of two instances in which young women applied these preparations before laser hair removal. They wrapped the affected areas in plastic wrap to increase the numbing effect. Both women experienced seizures, became comatose and died. FDA has other reports of serious side effects from these anesthetic skin preparations, including cardiac arrhythmias, coma, and respiratory failure.
If patients are considering medical or cosmetic skin procedures, advise them to consult a healthcare professional about whether a topical anesthetic is needed and, if so, how it can be safely used.
Here are some recommendations for patients to consider:
• First, patients should be advised to use a topical anesthetic approved by FDA. These can be found by searching for its name or active ingredient in FDA’s Electronic Orange Book of Approved Drug Products. If it is not there, it may not be approved.
• Patients should use a topical product that contains the lowest concentration of anesthetic drug that will satisfactorily relieve pain. They should apply as little of the product as possible, for the shortest possible time.
• Patients should get instructions from a healthcare professional on how to safely use the product, particularly if there will not be medical supervision during the procedure. They should understand that wrapping the skin or increasing its temperature will increase absorption of the drug into the body and thus increase the likelihood of adverse events. Absorption is also increased if the product is applied to broken or abraded skin.
• Certain patients, including those with respiratory problems, cardiac conditions, or susceptibility to seizures, may be at increased risk of life threatening adverse events if these topical anesthetic agents are used. For these individuals, the safest use is under the direct supervision of health care personnel.
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