WASHINGTON -- Hundreds of thousands of children with asthma and allergies find relief, even lifesaving treatment, from inhaled steroids. Now studies are finding the drugs also may slow some children's growth, and doctors are wrestling with what to tell parents.
There's no proof that these children will be shorter adults -- their growth could catch up. Research simply hasn't lasted long enough to tell, or to predict that even if final height is stunted, that it would be more than, say, an inch.
The drugs are critical to many children -- they have revolutionized asthma care -- so nobody wants youngsters to stop taking them.
But at the urging of lung specialists, more children than ever before are inhaling the medicines, starting at younger ages and lasting throughout childhood. So the Food and Drug Administration is struggling with how to explain the possible side effect without unduly alarming people. It also wants to find out exactly how big a concern it really is.
"We in no way are trying to frighten clinicians or parents," stressed Dr. John Jenkins, FDA's pulmonary drugs chief. The goal is "to promote the safest use of these drugs."
The FDA wants to put a warning label on the inhaled steroids, saying they may temporarily slow children's growth, that long-term effects aren't known, and that pediatricians should carefully chart every child patient's growth.
The agency also is debating how to make manufacturers determine the lowest effective dose of each drug, because lower doses should mean less risk.
At issue are corticosteroids. They come in a pill form that, if taken for long periods of time, is widely known to stunt growth and cause other side effects.
But newer versions that are inhaled or squirted up the nose -- sold under a variety of brand names including Beconase, Flonase, Pulmicort and Flovent -- cause fewer side effects because most of the medicine travels straight to the lungs or nasal passages, not through the whole body.
They control inflammation in patients with asthma or allergic rhinitis. Most importantly, they can prevent damage to the airways that worsens asthma.
But new studies show the medicines also can slow children's growth, the FDA told an advisory committee of lung and growth experts last month.
Children treated for a year were, on average, about half an inch shorter than expected. A few children, more sensitive to the drugs, were about an inch shorter, Dr. David Allen of the University of Wisconsin told the panel.
Half an inch doesn't sound like much, Allen acknowledged. Once children hit puberty, they might experience a growth surge and catch up. But the studies didn't last long enough to tell, or to know if years of treatment starting at early ages would slow growth more.
Whether the effect is worth worrying about is controversial among doctors.
Manufacturers argue it's just a short-term blip.
"There's little evidence these drugs actually stunt growth," said Dr. Tushar Shah of Glaxo Wellcome Inc., which makes several of the products. He said Glaxo's data show its Flovent brand may not even cause the short-term growth loss of older competitors.
The FDA says there's no proof that one inhaled steroid is better than another.
Last month, FDA's advisers endorsed its proposed warning labels and frequent growth measurements. The committee stressed that manufacturers should study child patients through adulthood to prove whether growth catches up.
But the concern comes at an awkward time when lung specialists are trying to get more asthmatics to use the inhaled steroids. They say too few of the 4.8 million child asthmatics are prescribed the medicines, and new federal guidelines recommend that even people with mild asthma use them daily.
"As a parent of a child and grandchild with asthma, I accept the downside," said FDA adviser Dr. Robert Kreisberg of Birmingham, Ala.
For allergy sufferers, who can try antihistamines instead, the issue may be more controversial. As one doctor wrote in this month's journal Pediatrics, the quandary "means that we should not be spraying (the drugs) into the nose of every child with a little nasal congestion."