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FDA permits manufacturers of oral health care benzocaine products to include a methemoglobinemia warning

The U.S. Food and Drug Administration advised the Consumer Healthcare Products Association (CHPA) on May 12, 2014 (PDF - 57KB), that the agency is permitting manufacturers of over-the-counter (OTC) oral health care benzocaine products to include a warning on the product label regarding methemoglobinemia.

Methemoglobinemia, while rare, is a serious health condition requiring prompt treatment.  FDA has issued an alert to health care professionals and consumers about the risks of methemoglobinemia associated with benzocaine products. 

Following FDA’s alerts in 2011 and 2012, CHPA member companies wrote to FDA requesting permission to include methemoglobinemia warnings on the labels for OTC oral benzocaine products. Current labels for OTC oral health care benzocaine products, including liquid, spray, lozenge, and topical gel, do not include a methemoglobinemia warning.

Although such a warning is outside the current label specifications in the Tentative Final Monograph for Oral Health Care Drug Products for OTC Use (PDF - 9MB), after careful review, FDA is now advising manufacturers, including non-CHPA members, that the agency will not object if companies add the following warning to the products’ Drug Facts:

“METHEMOGLOBINEMIA WARNING (these two words in bold print and capital letters as the first statement under the heading “WARNINGS”): Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy”

As new information becomes available about OTC oral health products and methemoglobinemia, FDA may revise or withdraw the decision to exercise discretion on benzocaine product labels.

Page Last Updated: 11/07/2016
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