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FDA WARNS AGAINST ANOTHER “TEETHING MEDICINE”

With a source of discomfort as common as teething in infants–that would be an incidence of about 100%–parents are familiar with the wide variety of approaches to the pain that are utilized.  Probably the most familiar is the use of topical products, that is, liquids that are rubbed on the gums for relief.  One those, viscous lidocaine (a prescription agent) became the subject of an FDA warning on June 26 that will carry the strong “black box” warning requirement.  A study by the agency earlier this year revealed several cases of severe side effects including  jitteriness, confusion, swallowing problems, seizures and heart problems, and several fatal cases were reported. These  problems occurred either due to overdose due to medication swallowed when the syrup was put in a bottle or on a cloth,  or was too frequently or generously applied to the gums.  In other cases a child ingested the medication from a bottle.  Viscous lidocaine is more often used in older children and adults for more severe and painful mouth sores from viruses or other causes.   But this warning has made clear that is should not be used for infant teething.

Lidocaine has never been used as commonly as benzocaine, which is over-the-counter and is found in those well-known products such as Orajel, AnbesoL, Hurricaine, and Orobase.  However, benzocaine  itself was the target of a 2011 FDA warning due to its role in causing a rare condition called methemagobinemia, in which the capacity for the blood to carry oxygen is impaired, causing cyanotic color,shortness of breath, fatigue, and some other problems.   This warning was not as strong, and the risk is probably quite low, but any medication should be safely stored to avoid accidental ingestion.

So what did the FDA  suggest for teething pain?  Reflecting the AAP’s own recommendations only some pretty simple stuff:  gently rubbing the gums with the caretaker’s finger and offering the baby a cool (not overly cold or frozen) teething ring or clean wet washcloth to chew on.  The coolness offers some good anesthetic for a short while, and does so without side effects–as long as there is  supervision to prevent aspiration of the cloth or teething ring.

The FDA did not appear to address the other common  measure for  teething discomfort,  acetominophen ( Tyenol, ect.) and ibuprofin (Motrin, etc.),  and this was a curious omission in the recommendations.  These are widely recommended by pediatricians and reliable online sites, and their safety profile is well established. Ibuprofin should not be used under six months of age, and acetominophen  has some safety preference.

Final note: teething is as normal part of childhood and on average there is going to be a new tooth to deal with almost monthly starting on average from six months and continuing   to about three years of age.  That’s 20 episodes.  So it makes sense to perceive any “need” for treatment in balance,  and certainly to avoid any agents with the potential for harm.  As an aside, it is worth noting that families often incorrectly  attribute symptoms to teething which it does not cause.  When there is significant fever, diarrhea, vomiting or impressive irritibility some other source must be sought.