FDA: No immediate ruling on cold meds for kids

http://www.cnn.com/2008/HEALTH/10/02/cold.medicines.ap/index.html

WASHINGTON (AP) -- A top government health official rejected the idea of an immediate ban on cough and cold medicines for young children, saying it might cause unintended harm.

Experts say there is little evidence to support using over-the-counter cold and cough medicines for young kids.

Food and Drug Administration officials at a public hearing Thursday said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2-6.
The FDA is also worried that a ban -- as sought by leading pediatricians' groups -- might only drive parents to give adult medicines to their youngsters.
"That is a concern for us," said Dr. John Jenkins, who heads the FDA's Office of New Drugs. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."
With a new cold season coming, pediatricians are urging the government to demand a recall of over-the-counter cough and cold medicines for children younger than 6. The effectiveness of the medicines in children was never scientifically established, critics say, and problems with the drugs send thousands of kids to the emergency room every year.
"When a treatment is ineffective, its risks -- unless zero -- always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston, Massachusetts, told the FDA panel.
The FDA this year warned against giving OTC cold medicines to children younger than 2. At that time, officials said they expected to decide by spring on recommendations for youngsters up to 11. Now the agency is seeking more advice from doctors, industry and consumers -- and officials are not giving a timetable for a decision.