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 After a little girl swallowed less than a teaspoon of the product,
she was hospitalized with a dangerously fast heart rate and
dangerously low blood pressure that lasted until the next day,
report the authors, who call for child-proof bottles and sale of the
drug by prescription only.
“This is a very powerful hypotensive agent, some milliliters can
lead to severe hypotension in an infant,” said Dr. Isabelle Claudet,
lead author of the report in Pediatric Emergency Care.
Claudet, who heads the pediatric emergency department at Children's
Hospital in Toulouse, pointed out that Alopexy and Alostil – the
brand names under which minoxidil is sold in France to treat hair
loss - come with a pump dispenser, which is no longer child-proof
once opened.
She told Reuters Health the drug should not be available either
over-the-counter or on the internet. Claudet and her coauthors also
want parents and dermatologists to be aware of the side effects in
kids.
Minoxidil was originally marketed to lower blood pressure in
hypertensive patients who had not responded to other medications.
The drug has also been sold as a hair-growing solution for several
decades.
Although generally considered safe, past research has shown that
even a teaspoon placed on the scalp of an adult twice daily can
cause rapid heartbeat, salt and water retention or, in some cases,
heart attack, according to Claudet.
As a treatment for hair loss, the drug is typically sold in a
2-percent or 5-percent solution, according to the researchers. The
standard dosage is one milliliter (about one-fifth of a teaspoon)
applied to the scalp twice daily.
The seven-year-old girl in this study swallowed a bit less than a
teaspoon of Alopexy (5 percent minoxidil) and was brought to
Claudet’s emergency room after vomiting all night.
Her blood pressure on admission was 86/56 mm Hg, plummeting to 79/33
mmHg at one point. Her pulse was rapid at 149 beats per minute. She
was given saline fluid, which had no immediate effect, but her blood
pressure went back to normal on the second day.
The girl’s mother said she had been giving her daughter cough syrup
for two days, and in the middle of the night when she heard the girl
coughing, the mother accidentally grabbed the wrong bottle from
underneath her own bed and gave her child the spoonful of medicine.
The dosage the girl ended up swallowing was 10 to 100 times greater
than the therapeutic dose at which minoxidil is used to treat
hypertension in children, the study authors note.
The drug swallowed by the little girl was manufactured by Pierre
Fabre Laboratories in Switzerland. Johnson & Johnson Healthcare
Products, a division of McNeil-PPC, Inc sells Rogaine, a similar
topical minoxidil solution, in North America.
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“The main problem is that it is considered as a safe product because
it is used for its hair effect, but people forget its main
indication as a hypotensive agent,” Claudet told Reuters Health by
email. “At therapeutic dosage, there is usually no serious adverse
effect, but for a child, some milliliters or a teaspoon can lead to
long-lasting hypotension.”
A representative of Johnson & Johnson said their Rogaine brand
products have “child-resistant features in most countries.”
Peggy Ballman, director of communications for the J&J Consumer
Group, wrote in an email, “The product packaging for minoxidil, the
active ingredient in both men’s and women’s ROGAINE Brand products,
includes an important warning to keep the product out of reach of
children,” adding, “We believe the first line of defense against
accidental ingestion is parental supervision, secure storage and
ongoing safe use education.”
Dr. Michael Wahl, medical director of the Illinois Poison Center,
said many over-the-counter drugs could be dangerous for kids if
taken at the wrong dosage.
“I think from a medication safety standpoint you always have to have
the lights on, read the bottle to confirm the medicine you want to
take and use the correct measuring device, like a syringe that will
say 5 ccs or 10 ccs as opposed to a teaspoon or tablespoon from the
kitchen,” said Wahl, who was not involved in the study.
“It really doesn’t matter if it’s minoxidil (or another drug),” he
said, “because this error could happen with a variety of just about
anything that’s in the medicine cabinet.”
Wahl added that while any potentially dangerous consumer medication
should be child-resistant, neither better packaging nor selling the
drug only by prescription would have likely mattered in the study
case.
Claudet said she hoped the case study sent a message to
manufacturers and retailers of minoxidil about its risks for
children.
SOURCE: http://bit.ly/12qqOOL Pediatric Emergency Care, online
November 25, 2014.
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