其 他 安 全 警 示
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| The United States: Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia(English Only) |
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U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
Currently labels of marketed benzocaine products in U.S. are not required to warn about the risk of methemoglobinemia, even though the use of benzocaine can cause this serious condition. FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.
FDA recommended that these 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 to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250264.htm
In Hong Kong, there are two pharmaceutical products containing benzocaine registered for topical oral use. Both products are part I poison and should be sold under the supervision of a pharmacist. One product is approved for children 2 years of age and older and the other is approved for children over 3 years of age. The above issue will be discussed in the coming Registration Committee of the Pharmacy and Poisons Board. Letter to inform the healthcare professionals will also be issued. The Department of Health will be vigilant on the related development in U.S and other countries.
Ends/ Friday, April 8, 2011
Issued at HKT 15:30
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