Benzocaine Safety Concerns Prompt FDA Statement
Benzocaine is a common local anesthetic. It is widely used to relieve pain as an ingredient in sprays, creams, and gels applied to the skin to treat sunburn, soreness, and insect bites. It is also an ingredient in oral pain relievers to treat sores and to numb areas in medical and dental procedures. Some of the most commonly known products containing benzocaine are Orajel, Solarcaine, and Anbesol.
A known but rare side effect of the drug is methemoglobulinemia, where oxygen in the blood stream is reduced. Recent injuries, including three deaths, prompted FDA to recommend stricter guidelines for administration of oral benzocaine. FDA does not require benzocaine labeling to warn consumers of the risk of this condition.
FDA’s communication to the public urges strict adherence to labeling for adult use. In children, FDA recommends that benzocaine not be given to children under 2 years of age except under medical advice and supervision. While noting that an excessive dose correlated to some of the injuries, FDA also stated that some injuries were not the result of excessive doses of benzocaine.
DangerWatch Drug List
DSE DangerWatch Drug List – Oct-Dec 2009
1.Severe and potentially life-threatening Allergic Reactions including
Anaphylaxis, Hypersensitivity and Autoimmune reactions.
-Diclofenac
-Gadolinium
-Mecasermin
-Minocycline
2. Liver failure
-Sunitinib