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FDA will receive this Friday a recommendation from a
committee of outside experts if cough and cold medicines should still be sold
for children up to age 12.
A week ago, major manufacturers like Wyeth, Prestige Brands,
Johnson & Johnson and Novartis decided to withdraw their cough and cold
products for infants. Linda A. Suydam, president of trade association, said the
reason for this voluntary withdrawal is safety. She added that “there have been
rare patterns of misuse leading to overdose recently identified, particularly
in infants”.
Three weeks ago, the Consumer Healthcare Products
Association and safety reviewers within the Food and Drug Administration
recommended not using the products on infants and even proposed a market ban of
over-the-counter cough and cold products for children under 6.
Cough and cold medication for infants was approved a long
time ago on the assumption that children were just small adults and drugs that
were tested on adults should work on children too.
Dr. Joshua Sharfstein, health commissioner for the city of Baltimore, referring to
cough and cold products for children, said: "FDA has permitted widespread
marketing that is not supported by scientific evidence".
New studies show that these drugs actually have no effect on
children or, even worse, they could even hurt them.
Sharfstein and other physicians are asking the government to
restrict selling these drugs for kids up to age 6.
Drug makers say that problems after using the medicines
followed an accidental overdose. "Some parents and caregivers need better
information on how to use these medicines appropriately", said Linda
Suydam.
95 million cough and cold products for children are sold
every year.
The FDA usual follows the advisory panels’ recommendations.
And today, the FDA’s advisory panels on nonprescription and pediatric drugs
will hear from doctors, drug makers and FDA staff on the safety and
effectiveness of cold and cough medicines for children. They will also debate
and decide on recommendations that may include banning marketing, adding label
warnings or requiring studies in children.
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