FDA WARNING: “FAREWELL BABY TYLENOL DROPS” REVISITED

In May of last year, I posted an article titled, “Farewell Baby Tylenol Drops.”  The item described the industry-wide decision to discontinue the  more concentrated drops form of acetominophen for infants in favor of the lower concentration which previously made up the  syrup (160 mg. per 5 cc.)   There would be separate packaging and a dosing syring for infants. The purpose of this conversion to a single dose product was to eliminate the dosage error– both over and under dosing –due to confusion as to just which form the family had in hand.

In theory this should eliminate the confusion and inappropriate dosing.  But, as is so often the case, we deal with practicality and not theory.  And the reality is that there is still some of that far more concentrated product on store shelves, and certainly lots in family homes.  And the latter is likely to remain the case for some time. 

Because of the this the F.D.A. issued a reminder warning in December, that parents and other caretakers should exercise care in giving babies, especially young infants, acetominophen.  Specifically the Agency is making these recommendations (verbatim from its bulletin):

  • Read the Drug Facts label on the package very carefully to identify the concentration of the liquid acetaminophen, the correct dosage, and the directions for use.
  • Do not depend on a banner proclaiming that the product is “new.” Some medicines with the old concentration also have this headline on their packaging.
  • Use only the dosing device provided with the purchased product in order to correctly measure the right amount of liquid acetaminophen.
  • Consult your pediatrician before giving this medication and make sure you’re both talking about the same concentration.

Through this consultation,  when medical staff is calculating a dosage based on weight, the volume you will be administering  neither more nor less medication  than efficacy and safety  require.   The F.D.A.’s Carol Holquist listed these additional precautions about more quantitatively detailed dosing accuracy:

  • Look for the “Active ingredient” section of the Drug Facts label usually printed on the back of an over-the-counter (OTC) medication package. 
  • If the package says “160 mg per 5 mL” or “160 mg (in each 5 mL)”, then this is the less concentrated liquid acetaminophen.  This medication should come with an oral syringe to help you measure the dose.
  • If the package says “80 mg per 0.8 mL” or “80 mg per 1 mL,” then this is the more concentrated liquid acetaminophen. This product may come with a dropper.

The bulletin concluded by listing the many  brand names under which acetiminopen for infants is marketed, but they should  uniformly list acetominophen as the active ingredient.