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The Department of Health (DH) today (April 8) cautioned the public about the use of benzocaine products because of its potentially fatal side effect, methaemoglobinaemia.
The DH, through its pharmacovigilance scheme, noted that the US Food and Drug Administration (FDA) alerted healthcare professionals and patients that it continued to receive reports of methaemoglobinaemia associated with the use of benzocaine products, whether as sprays during medical procedures to numb the mucous membranes of the mouth and throat, or as gels and liquids to relieve pain in a variety of conditions, such as teething, canker sores and irritation of the mouth and gums. Though rare, the condition is very serious as it can be fatal due to reduction in the amount of oxygen carried in the blood. It can occur with all strengths of benzocaine sprays, gels and liquids, and tends to affect mainly children aged two years or younger.
While FDA is continuing to evaluate the safety of benzocaine products, it recommends that such products should not be used in children less than two years of age, except on the advice of a healthcare professional. For adults who use benzocaine gels or liquids to relieve pain in the mouth, etc, they ought to follow the recommendations in the product labels.
In Hong Kong, two pharmaceutical products containing benzocaine are registered for topical oral use. Both products must be sold under the supervision of pharmacists. One product is approved for children aged two and over, and the other is approved for children over three years of age. So far, no adverse event report has been received by DH.
A spokesman from DH remarked that the issue would be discussed in the coming meeting of the Registration Committee of the Pharmacy and Poisons Board. "Meanwhile, the DH will remain vigilant and continue to monitor related developments worldwide. Moreover, the DH will also write to alert healthcare professionals and advise them to report any unusual side effect(s) noted with the use of benzocaine products," he added.
The spokesman also reminded patients to consult their healthcare professionals if in doubt or feel unwell after usage of the concerned products.
Ends/Friday, April 8, 2011
Issued at HKT 20:06
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