Responding to safety concerns from Baltimore health officials, the FDA is recommending that common cough and cold medicines never be given to infants and toddlers, and that children under 6 should not be given antihistamines.
In a 356-page report released yesterday, the agency also proposes that warnings about the dangers of overdosing children be added to the labels of these widely used over-the-counter medications.
But the Food And Drug Administration's preliminary recommendations appeared to stop short of the blanket warning proposed by a national pediatricians' group and a group of doctors led by Baltimore's health commissioner, Dr. Joshua M. Sharfstein. They want the agency to advise against giving cold medicines to any child under 6.
Sharfstein said the evidence presented by the FDA suggests that the agency will adopt his more aggressive stance on the medications when it makes a final decision this year.
"You have hundreds of pages of review here, and no one is saying these products are safe or effective," he said. "That's nowhere in here - and if that's the case, they shouldn't be used."
An FDA advisory panel will take up those issues at hearings next month. The pediatric dosage guidelines currently used were approved more than 30 years ago. Critics point out that they were based on doses approved for adults, because few studies had been conducted on children.
"The whole idea was, if a disease is the same in adults and in children, you can normally extrapolate a dose for children," said FDA spokeswoman Susan Cruzan. "That is what's happened over the years. ... With all these issues being raised - safety concerns - we're going to go back and look at it."
In their petition to the FDA, Sharfstein and other doctors pointed to the deaths of four Baltimore children under age 4 in the past six years that were linked to cough and cold medications.
The FDA's review found that from 1969 through the fall of 2006, there were 54 reported deaths involving decongestants, and 69 with antihistamines - mostly in children younger than 2 years.
As their name suggests, decongestants are drugs designed to relieve stuffy noses by reducing swelling of the mucous membranes in nasal passages.
Antihistamines relieve runny noses, itching, sneezing, and watery eyes. They can also cause drowsiness.
The two types of drugs are often combined, sometimes with cough suppressants, in cold remedies.
