Hazard Alert! INFANTS’ TYLENOL
From the June 27, 2001 issue of MSA Acute Care Edition Newsletter A front panel band on the carton of Rugby brand Pain &
Fever Drops (acetaminophen drops) suggests
that it is comparable to INFANTS’ TYLENOL Concentrated
Drops (acetaminophen drops). Both products contain acetaminophen,
100 mg/mL, which has had a history of confusion with children’s
acetaminophen elixir (160 mg/5 mL). Mothers who were instructed
to give a “teaspoonful of
Tylenol” to their child have used the concentrate in
error. In 1997, the July 16 and October 22 issues of the ISMP Medication Safety Alert! discussed fatal acetaminophen overdoses,
and a September Dateline NBC highlighted another overdose
victim, a child who needed a liver transplant. In our June
16, 1999 issue, we reported a hospital error where a child
with fever was prescribed “10 mL of acetaminophen per
protocol.” The nurse used Infants’ Tylenol instead
of children’s acetaminophen elixir. These overdoses led
McNeil Consumer Products to redesign the label of Infants’
Tylenol drops to emphasize the concentrated
form. They also developed a special SAFE-TY-LOCK package
with floppy “cusps” in the bottle’s neck that
admit a dropper, but act as one-way valves to prevent outward
gravity flow of the concentrated suspension, making it difficult
to pour teaspoonful amounts (see photo in the June 16, 1999,
issue on our web site). While the Tylenol product has these
safety features, the Rugby product does not, as
other manufacturers are not required to use similar packaging.
Further, Rugby’s outer carton does not list a
concentration. It states only that “each dropperful contains
80 mg.” Worse, once the carton is discarded, the dropper
bottle does not list the strength or concentration. If a different
dropper is used, the wrong dose may result. Also, the label
does not state that it is a concentrated form. It’s difficult
to understand why Rugby and other generic manufacturers aren’t
responsible for following the safety standard established
by McNeil. We’ve alerted FDA to investigate generic acetaminophen
concentrated drops packaging. Meanwhile, continue to remind
parents about the different concentrations.
In 1994, after several deaths and injuries were associated
with unrecognized calcium phosphate precipitation in 3-in-1
total nutrient admixtures, FDA published a safety alert with
useful guidelines to avoid the problem with parenteral nutrition
admixtures (Am J Hosp Pharm 1994;51:1427-8). The amounts of
phosphorous and calcium added in the same admixture are critical.
However, information about calcium
and phosphate compatibility in admixtures hasn't always been
readily available. We recently learned of a new publication
to guide compatibility decisions. Trissel's Calcium and Phosphate
Compatibility in Parenteral Nutrition (TriPharma Communications,
Houston, TX 77225-0124; tel. 713-838-2334) is a pocketsize
resource that combines available research and other information
on the subject. There will be fewer problems because of this
work.
