The US Food and Drug Administration needs more data on whether over-the-counter
cold medicines are safe and effective for children between 2 and 6 years old
before taking any action, a top agency official said Thursday at a public
hearing on the matter. These products include decongestants, expectorants,
antihistamines and cough suppressants.
The American Academy of Pediatrics are urging the government
to demand a recall of over-the-counter cough and cold medicines for children
younger than 6, arguing that the products are ineffective and problems with the
drugs send thousands of kids to the emergency room every year. This conclusion
was seconded last year by a panel of outside advisers to the FDA, but the
agency’s own advice is that parents should not give the medications to toddlers
under 2, a position shared by drug companies.
In January, the FDA 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 without establishing a timetable
for a decision. The FDA officials fear that once these drugs banned, the
situations might get worse, as parents might be tempted to treat their children
with adult medicines.
“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,” Dr. John Jenkins, who heads the FDA’s Office for New Drugs,
said.
Meanwhile, an estimated 7,000 children end up in hospital
emergency rooms every year because cough and cold medicines, according to a
study released by the US Centers for Disease Control and Prevention released in
January. Most of the kids take the medicines without their parents’ knowledge. Among
the serious adverse affects are neurological problems, increased blood
pressure, hallucinations, and even death. Some products packages show babies in
diapers, misleading customers.
Also in October 2007, the FDA said it had 54 reports of
death in children linked to decongestants containing the ingredients
pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and
69 reports of deaths linked to antihistamines with the ingredients
diphenhydramine, brompheniramine and chlorpheniramine. The agency said the bulk
of the reports were in children younger than 2. In addition, a number of the
deaths occurred in children who had gotten overdoses. The agency said that even
though there are warning labels on the drugs, advising parents to consult a
doctor before administering them to their children, many fail to follow the
advice.
Parents spend at least $286 million a year on cough and cold
medicines for children, according to the Nielsen Co. market research firm.
Another report released by Boston University researchers found that in any
given week the medicines are used by an estimated 10 percent of all children,
with the biggest exposure among 2- to 5-year-olds. Given these figures, it’s no
wonder there are so many kids ending in the ERs.
“With each passing month we see more unnecessary cases of
child poisoning from these products. The FDA should set and adhere to a strict
timetable for its actions,” Alejandro Necochea, a health research associate
with the Washington
consumer group Public Citizen told FDA officials. Moreover, other experts said
cold medicines have shown little benefit for children’s cold symptoms which
usually clear up on their own without medicine.
Meanwhile, pediatricians have released a number of rather
old-fashioned treatments for kids such as humidifiers, saline drops and
hydrating fluids such as classic chicken soup. For a child with more serious
symptoms, such as consistent, wheezing cough that persists for more than a few
days, parents should consider seeing a physician.
