DOCTORS SAY INHALER RISK OVERBLOWN

As word of a new federal alert circulates that common asthma inhalers
may slow children's growth, pediatricians are juggling calls from
worried parents and fearing that the precaution may deter patients
from taking their medication.

The Food and Drug Administration order has particular resonance in the
Chicago area, which has one of the highest concentrations of asthma
cases in the nation and is the subject of several long-term studies to
determine causes and better treatment for the sometimes-fatal condition.

Last week the FDA ordered that steroids inhaled or sprayed up
children's noses be relabeled to let parents and doctors know that the
drugs may temporarily slow children's growth--on average, one-third of
an inch a year, according to several studies.

Local doctors have been reassuring patients that in fact the FDA
precaution is just that and nothing more, and that the risks of not
taking the medication far outweigh the potential side effects.

"I think (the FDA order) sends a very wrong message. We already have
people terrified of steroids. There is no question that inhaled
steroids are the medication for treating asthma," said Dr. Raoul Wolf,
director of pediatric allergy and immunology at the University of
Chicago Hospitals and a board member of the American Lung Association
of Metropolitan Chicago.

The FDA decided to issue the change in labeling language because when
patient safety is at issue, officials feel it is best to inform
physicians and patients about clinical findings, even when some
questions remain unanswered, FDA officials said Thursday.

Dr. John Jenkins, director of the FDA's division of pulmonary drug
products, which is responsible for reviewing and approving all drugs
for treating allergic and lung diseases, said the precaution should
not scare patients from using the drug.

"It's a safety-related issue that should be taken into account when a
physician decides what drugs to use in a patient and how to monitor
that patient," Jenkins said. "We are not in any way suggesting these
drugs are not safe for use in children or that they should not be used
in children."

In the expert advisory meeting that overwhelmingly supported the
change, committee members based their decision in large part on new
research data that has not yet been published, Jenkins said.

"There was a lot of concern . . . about the phenomenon referred to as
`steroid phobia,' " Jenkins said.

At issue are corticosteroids. When taken in pill form, the drug is
known to slow growth.

Marci Schiavi of Barrington called her doctor last week with questions
about the FDA precaution. The mother continues to struggle over
whether to keep her 5 1/2-year-old son, Nickolas, on a steroid inhaler.

She reluctantly put the youngster on the therapy at age 3. Back then,
Schiavi said, doctors told her the drug wouldn't affect his growth or
any of his organs--and so far, she doesn't think it has.

Nickolas has responded well to the treatment. Right now, he inhales
only twice a day. Schiavi, who takes her son to Children's Memorial
Hospital in Chicago for care, wonders what other drug her son can use
that will work as well as his steroid inhaler.

The FDA warning makes Schiavi want to wean her son off the drug, but
she fears doing that will cause a severe relapse of his asthma condition.

"The whole thing still scares you either way," Schiavi said of the
decision to medicate Nickolas. "But he has to breathe."

Inhaled steroids are recommended by experts as the most effective,
long-term therapy for mild to severe asthma, and they help prevent an

asthma attack that can land a youngster in the hospital.

The FDA precaution, which also includes nasal steroids that are
generally used to treat allergy-related nasal symptoms, is not on the
product itself, but must be included in the package insert. It affects
about 20 products.

"Right now in the clinic, the patients we see are very cognizant of
this report," said Dr. Sai Nimmagadda, assistant professor of
pediatrics and physician in the allergy division at Children's Memorial.

"What worries me is a lot of patients will read that but not contact
their allergist or pulmonologist and find out if those concerns are
valid in the patient they are treating," Nimmagadda said.

Researchers don't know whether a child's long-term height will be
affected by the drug. The FDA label recommends that pediatricians
chart patients' growth carefully and prescribe the lowest possible
dose.

Asthma is a chronic illness, and any child with a chronic illness may
have growth delay, regardless of whether they are using inhaled
steroids, physicians said.

"The risk of not treating asthma is much greater than the risk you'll
see in the potential side effect," said Dr. Edward Naureckas,
assistant professor of clinical medicine at the U. of C. Hospitals and
chair of the executive committee of the Chicago Asthma Consortium.

Maureen Damitz of the Far North Side, an asthma sufferer who has three
children with the condition, has known about the possible growth
complications caused by steroid inhalers for years. One of her sons
even experienced a downturn in his growth as a result of steroid therapy.

But she is a believer in the drug, saying it has kept 9-year-old Kyle
alive.

"We are keeping him on inhaled steroids because we cannot maintain him
without it," Damitz said. "Dealing with asthma is like a juggling
game. You know the medicines come with risk, but you know without the
medicine there are severe risks. While we know it's not the ideal
drug, we know he wouldn't be here without it."

Checked-by: Rich O'Grady