Health

FDA Warning: Benzocaine Teething Product May Kill Babies

| by Mitzi Dulan

Over the last several years there have been various reports regarding the dangerous side effects related to the usage of benzocaine products and just this April the FDA posted a caution to healthcare providers and patients that some individuals using benzocaine, which can be found in over the counter gels and liquids, have experienced Methemoglobinemia, a condition in which oxygen levels plummet, in some cases resulting in death.   

This side effect has been connected to all strengths of benzocaine gels and liquids and the majority of methemoglobinema cases involve children of two years and younger.  Benzocaine can be found in everything from teething gels to cough drops. 

Signs of methemoglobinemia include shortness of breath, headache, fatigue, rapid heart rate, lightheadedness and blue colored skin, lips, and nails.   Recommendations for benzocaine usage as well as what to do if you experience a reaction that are found in the FDA article include the following:

RECOMMENDATIONS:

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  • Benzocaine 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.

Healthcare professionals and patients 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:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
  • Download form2 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

So what can you do to relieve discomfort? For teething infants you can use appropriate teething rings that can be chilled in the refrigerator or freezer.  

You can also use an organic wash cloth. Just moisten it and place it in the fridge or freezer.  You can knot it to give your child something more substantial to chew on. Hot tea with a little honey and lemon can help to sooth a sore throat.

Remember that many over the counter products are not regulated by the FDA and the once a regulated product is on the market, the FDA cannot pull it from the shelf without substantial proof that it is dangerous to consumers. 

Be sure to always follow correct dosing guidelines and contact your healthcare provider with questions or concerns.

Research Assistance Provided by:  Sarah Volling