Monday, January 19, 2009

FDA: Skin Numbing Products Can Be Life Threatening

The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.

Skin numbing products are used to desensitize nerve endings that lie near the surface of the skin, causing a numbness of the skin. These topical anesthetics contain anesthetic pharmaceutical drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. When applied to the skin surface, they can be absorbed into the blood stream and, if used improperly, may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma, or even death. FDA has received reports of adverse events and deaths of two women who used topical anesthetics before laser hair removal. In February 2007, the FDA issued a Public Health Advisory - “Life-Threatening Side Effects with the Use of Skin Products containing Numbing Ingredients for Cosmetic Procedures,” to warn consumers about these products.

The FDA strongly advises consumers not to:
  • make heavy application of topical anesthetic products over large areas of skin;
  • use formulations that are stronger or more concentrated than necessary;
  • apply these products to irritated or broken skin;
  • wrap the treated skin with plastic wrap or other dressings; and
  • apply heat from a heating pad to skin treated with these products.

The following summarizes advice for patients if a topical anesthetic is recommended for their use:
  • 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; and
  • 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.
Go to the FDA release

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