According to recent safety reviews released by the FDA (Food
and Drug Administration) shelves full of cough and cold medications marketed
for babies and toddlers should be avoided due to increasingly high bad feedback
from doctors.
In effect with the review, pediatricians have released a
number of rather old-fashioned such as include humidifiers, saline drops and,
yes, hydrating fluids such as the classic chicken soup. For a child with more
serious symptoms, such as a consistent, wheezing cough that persists for more
than a few days, parents should consider seeing a physician
On October 18, the FDA plans to hold a public meeting of a
group of outside advisers to examine the safety and effectiveness of over-the-counter
cough and cold medicines for babies and young children, which are sold under a
range of brands, including Wyeth's Robitussin, Novartis AG's Triaminic and
Johnson & Johnson's Tylenol Plus Cold. On Friday, in advance of the
meeting, the agency unveiled in-depth reviews of the issues, by its own experts
and some other groups.
Though the FDA hasn't come to a final conclusion about how
to deal with the drugs, a number of the reviews echoed alarm bells that doctors
had earlier raised. Agency safety reviewers wrote that an analysis suggested
that the use of some of the medications has been associated with serious side
effects and some deaths in patients younger than 6 years old. They also noted
that the drugs haven't been proven to work in children.
The FDA said Friday it had 54 reports of deaths 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. Also, a number of the deaths occurred in
children who had gotten overdoses.
However, doctors say, some drugs are appropriate for kids
with cold-like symptoms. Ian Paul, an associate professor of pediatrics and
public health sciences at the Penn State College of Medicine who has done
research on pediatric use of the cough medications and is now consulting for
some of the products' makers, says he doesn't advise their use for colds. But
"antihistamines work well for allergies," he says, and he will use
them in kids for that. For pain, children's or infants' versions of
acetaminophen, or Tylenol, are also acceptable for young kids, he says.
Other doctors suggest that the real issue to pay attention
to is misuse and that the medications can be helpful when used properly.
Jonathan Field, director of the Pediatric Allergy, Asthma and Immunology Clinic
at New York University Medical Center/Bellevue Hospital, says he suggests that
parents check with a pediatrician.
