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FDA: Benzocaine may be associated with methemoglobinemia
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Cases of methemoglobinemia after benzocaine use continue to be reported to the FDA, and therefore, benzocaine products should not be used on children aged younger than 2 years, according to an agency press release.
Methemoglobinemia has been linked to benzocaine products used as a spray, during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter.
Cases have been reported primarily in children aged 2 years or younger who were treated with benzocaine gel for teething. Common symptoms include pale, gray or blue skin, lips and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. The signs and symptoms usually appear within minutes to hours of applying the product. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported after the administration of a single benzocaine spray.
The FDA advises that benzocaine products not be used on children aged younger than 2 years, except under the supervision of a health care professional.
The FDA is continuing to evaluate the safety of benzocaine products and will update the public when it has additional information, according to the release. Health care professionals are encouraged to report adverse events, side effects or product quality problems related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
This announcement and warning from the FDA raises several notable points. Benzocaine-containing products are commonly available and obtained over-the-counter, potentially without a health care provider’s specific recommendation or knowledge of use. Availability of medications OTC does not necessarily equate to less risk of adverse effects. Health care providers may wish to consider this when obtaining medical and drug histories. In place of OTC pediatric benzocaine products, children who are teething may benefit from use of a cold teething ring or local gum massaging. It is important for health care providers to closely follow the medical news for announcements such as this information about benzocaine-containing products.
—Edward Bell, PharmD, BCPS
Infectious Diseases in Children Editorial Board
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