The FDA has notified healthcare professionals and patients that it continues to receive reports of methemoglobinaemia, a serious and potentially fatal adverse effect, associated with topical benzocaine products.

Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

The Agency advises that benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional. Adult consumers who use benzocaine gels or liquids should follow the recommendations in the product label and should store benzocaine products out of reach of children.

Further information is contained in two Drug Safety Communications which can be accessed from the press release at the link below.