Premier Pigments
News/Press Releases
FDA Warning:
Topical Anesthetics Have Potential Life Threatening Side Affects
Arlington, TX -- February 13, 2007 --
The US Food and Drug Administration issued an advisory to alert the public to the potential hazards of using skin numbing products, also known as topical anesthetics, for cosmetic procedures.
These topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine formulated in a cream, ointment, or gel and the FDA has approved these products for specific uses. Applying topical anesthetics for a medical procedure is usually done in a clinical setting by a trained professional. However, FDA is aware that unsupervised clients may apply large amounts of topical anesthetics to their skin. This application can result in high levels of these products in the blood causing life-threatening side effects, such as an irregular heartbeat, seizures, and death.
Topical anesthetics are sometimes used in ways not approved by the FDA and at doses that may pose a risk for serious harm to consumers.
FDA is aware of two instances where women, aged 22 and 25 years old, applied topical anesthetics to their legs to lessen the pain of laser hair removal. These women then wrapped their legs in plastic wrap, as they were instructed, to increase the creams’ numbing effect. Both women had seizures, fell into comas, and subsequently died from the toxic effects of the anesthetic drugs.
FDA also has received reports of serious and life-threatening side effects such as irregular heart beat, seizures and coma, and slowed or stopped breathing following the use of these numbing products. These effects happened in both children and adults and when the anesthetic drug was used both for approved and unapproved conditions.
###
Back to Premier Pigments News/Press Releases |