U.S. FDA Issues Safety Notice for OTC Benzocaine Products
May 23, 2018 – The U.S. FDA has issued a safety communication in regards to the use of over-the-counter (OTC) benzocaine products in children younger than two years of age. Benzocaine is a local anesthetic commonly used to relieve oral pain.
According to the notice, oral benzocaine drug products “carry serious risks and provide little to no benefit for treating oral pain, including sore gums in infants due to teething.” The FDA also cautions that benzocaine can cause methemoglobinemia, a potentially life-threatening condition in which blood oxygen levels are reduced significantly.
The FDA is calling on manufacturers to stop marketing OTC oral benzocaine products to treat teething in children younger than two years old. It has threatened to take action to remove such products from the market if manufacturers do not comply.
In addition, the FDA has instructed manufacturers to add the following warnings to any OTC benzocaine oral products marketed for adults and children at least two years of age:
- Advise consumers of the risk of methemoglobinemia;
- Include contraindications to make consumers aware that the products should not be used to treat teething or in children under the age of two; and
- Revise product directions to indicate the product should not be used in children younger than two years old.
The FDA also announced that it will require a standardized methemoglobinemia warning be included in the product labeling for all prescription local anesthetics.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.