FDA Mulls Limits on Kids' Cough Medicine
Some Experts Want to End Sales of Over-the-Counter Cough and Cold Medicine for Children
Oct. 2, 2008 -- Consumer groups and medical experts called on the FDA
Thursday to pull children's cough and cold medications off the market or make them available only
The pleas come as regulators mull a possible crackdown on over-the-counter
cough and cold medicines for children, sold by the millions in pharmacies and
Last summer, the FDA warned consumers not to give cold medicines to children
under age 2 because of serious and possible life-threatening side effects. Now
officials are considering limiting sales of products intended for children up
to age 6.
The FDA estimates that as many as 800 cough and cold medications are on the
U.S. market. Companies sell an estimated 95 million packages of pediatric cough
and cold medications each year, according to Information Resources, a market
"A lot of people don't know that the FDA has never required companies to
show their products are effective," said Paul Brown, government relations
manager at the National Research Center for Women and Families.
The agency's options range from stricter labeling and packaging requirements
to banning companies from marketing products targeted for young children at
Joshua Sharfstein, MD, the Baltimore City Commissioner of Health, urged FDA
officials to take off the market cough and cold medicines for children under 6.
He also said the regulators should recall millions of those packages currently
on store shelves. "Parents should know that there is less evidence than
ever to support the use of over-the-counter cough and cold medicines for young
children," he said.
The agency is also considering moving children's cold medicines from
over-the-counter status to prescription-only sales.
"The cost to the health system would be enormous," Linda Suydam,
president of the Consumer Healthcare Products Association, told WebMD. The
group is the main trade organization for companies making cold remedies.
Lack of Data on Cold Remedies for Kids
Most available cold remedies use combinations of different active
ingredients, and most have not been well-tested in young children, critics said
At the same time, about 7,000 children under 11 go to emergency rooms each
year after taking cough and cold medicines, according to the CDC. Roughly
two-thirds of those occurred after children drank medication while
unsupervised, the agency said.
But several experts told the FDA Thursday that cold medicines have shown
little benefit for children's cold symptoms, which usually
clear up on their own without medicine.
"The available data show cough and cold products to be ineffective for
children with cough and cold symptoms. In the absence of evidence of efficacy,
any risk associated with these drug therapies is unacceptable," said David
Bromberg, MD, a pediatrician from Frederick, Md., who testified on behalf of
the American Academy of Pediatrics.
Suydam told FDA officials and experts that the industry was planning dose
studies of cough and cold medicines in children. She also said companies were
planning public campaigns to educate parents on how to safely use the products
It is likely to take years for the FDA to go through the process of changing
the rules for children's cold medicines, officials said.
John K. Jenkins, MD, who directs the FDA's Office of New Drugs, said the
agency is concerned that an outright ban on sales for children would drive
parents to use more adult medications for their kids.
"We're very concerned that we'd see a shift in people using adult
products," Jenkins told reporters. "Then you would have an even worse