Transcript Manufacturers Remove Drugs for Infant Cold

Manufacturers Remove Drugs
for Infant Cold
By GARDINER HARRIS
Published: October 12, 2007
http://www.nytimes.com/2007/10/12/us/12cold.html?adxnnl=1&adxnnlx=1192216228-Tg9wsOxwq9NFWBGk8/jaJQ
Product Withdrawal Recommended
2 Weeks Earlier
• WASHINGTON, Oct. 11 — Major makers of over-the-counter
infant cough and cold medicines announced Thursday that
they were withdrawing their products from the market for fear
that they could be misused.
• The voluntary withdrawal, already under way, affects only
products labeled for use in infants, not for use in children 2
and older. And some small companies could continue selling
infant products. More changes, perhaps mandated by federal
drug regulators, could be in the offing.
• The withdrawal comes two weeks after safety reviewers within
the Food and Drug Administration urged the agency to
consider an outright ban of over-the-counter cough and cold
products for children under 6. Even the industry’s main trade
group, the Consumer Healthcare Products Association,
recommended two weeks ago that the products not be used
in infants.
Industry Admits Some Patterns of
Misuse
• Despite the recommendation, giant drug makers like Johnson
& Johnson, Wyeth and Novartis continued to sell cough and
cold products labeled for infants. Last week, Representative
Henry A. Waxman, the California Democrat who is chairman
of the House Committee on Oversight and Government
Reform, sent a letter to the industry’s trade association asking
why the products were still being sold.
• Until Thursday, industry representatives answered that they
were discussing the issue with the F.D.A. and defended their
medicines as safe and effective.
• “The reason the makers of over-the-counter oral cough and
cold medicine for infants are withdrawing these medicines is
that there have been rare patterns of misuse leading to
overdose recently identified, particularly in infants,” said Linda
A. Suydam, president of the trade association.
• “Safety is our top priority,” Ms. Suydam added.
What We Know
• Next week, a committee of outside experts will consider the safety of
these medicines and offer recommendations to the agency. Dianne
Murphy, director of the agency’s office of pediatric therapeutics, said in
an interview that in addition to asking basic questions about the drugs’
safety and effectiveness, the agency intended to question the experts
closely about the advisability of combination medicines. It will also
explore how to address accurate dosing when there are a dizzying array
of measuring devices, some provided by the manufacturers and some
not.
• The experts will also consider whether children from 2 to 6 should be
given these medicines. “I don’t recommend their use in any child,” said
Dr. Daniel Frattarelli, a pediatrician from Detroit who serves on the
American Academy of Pediatrics’ committee on drugs. “These medicines
don’t help, they may hurt, so don’t use them.”
• There are 800 over-the-counter pediatric cough and cold products. In the
fiscal year that ended July 15, makers sold at least 41 million units of
these products in the United States, about a fifth in the form of drops that
are generally given to infants, according to the trade association. A 1994
study found that more than a third of all 3-year-olds in the country were
given over-the-counter cough and cold preparations in one 30-day span.
Evidence of Efficacy
• There is little evidence that cough and cold medicines are effective
in young children, and there are increasing fears that they may be
dangerous. From 1969 to 2006, at least 45 children died in the
United States after taking decongestants, and 69 died after taking
antihistamines, according to the F.D.A.
• Many children were sickened after they were mistakenly given too
much — either because parents failed to realize that products from
two makers contained identical medicines or because parents had
given improper amounts. But there are reports that even children
given recommended doses are at risk.
• Infant cough-and-cold products were approved decades ago
without adequate testing in children because experts assumed
that children were simply small adults, and that drugs approved
for adults must also work in children. More recent research
showed that neither assumption was true. Indeed, recent studies
suggest that pediatric cough and cold medicines work no better than
placebos.
The Economics
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