FDA Panel Considers Impact of Corticosteroids on Kids' Growth
Bloomberg News
July 30, 1998, 4:51 p.m. ET
FDA Panel Considers Impact of Corticosteroids on Kids' Growth
Bethesda, Maryland, July 30 (Bloomberg) -- Labeling on
inhaled corticosteroid drugs, commonly used to treat asthma,
shouldn't overemphasize their risks, drugmakers told an expert
government advisory panel.
The U.S. Food and Drug Administration called the panel to
consider the drugs' effects on children's growth, and whether
they should carry a standard precaution label. While the
potential effect on growth has long been noted, new concerns
about the corticosteroids cropped up after two drugmakers sought
to switch their drugs to over-the-counter use, the FDA said.
''It is indeed important that potential effects on growth
are defined,'' Anders Ullman, a vice president for clinical
research and development at Astra AB, told the panel. ''These
issues must not be overemphasized. That could definitely lead to
under-treatment of asthma.''
Astra's Ullman was joined by representatives from Glaxo
Wellcome Plc, Rhone-Poulenc Rorer Inc. and Schering AG, all
makers of the corticosteroids. While the company officials had
varying views of what should go on a standard label if one should
exist at all, they all told the panel that any new label must
stress that the drugs' benefits outweigh their risks.
The panel is scheduled to take up discussion of the label
and other issues tomorrow after hearing more presentations from
experts.
Inhaled corticosteroids are currently considered the best
option for treatment of patients with chronic asthma, a lung
disorder affecting some 15 million Americans. Analysts said a
label change wouldn't have an immediate effect on sales of the
drugs, which compete in a multibillion dollar market.
''The impact is likely to be more gradual,'' said Ira Loss,
an analyst with HSBC Washington Analysis.
New Alternatives
Still, a label with more severe warnings or one which
advises more frequent monitoring of growth could have an effect
''on the margins'' by encouraging patients and doctors to
consider treatment with new alternatives, said James Kelly, an
analyst with Credit Suisse First Boston.
That could be good news for companies including Merck & Co.,
Zeneca Plc and Abbott Laboratories which in the last few years
have introduced drugs in a new, non-steroid class of asthma
drugs known as leukotriene blockers. They work by blocking
substances in the body that act as co-conspirators in the
inflammation suffered by asthma patients.
Still, experts note that there's little long-term data on
the newer drugs.
FDA officials said they called this panel meeting because
they're trying to figure out the best way to use corticosteroids
and emphasized that they don't consider them unsafe.
''We in no way today are trying to frighten physicians or
parents about the use of corticosteroids,'' said John Jenkins,
director of the division that oversees pulmonary drugs. ''We're
not trying to induce steroid phobia.''
Indeed, several experts speaking today noted that the drugs,
which work by reducing the inflammation that exacerbates asthma,
have a long, safe history of use.
National Institutes of Health guidelines released last year
recommended their use, calling them ''the most effective long-
term control medication for asthma.'' The NIH also said the
benefits of the drugs outweighed the risk of stunted growth.
Risk Unclear
And even that risk isn't agreed upon by everyone. Some of
the company representatives said their studies have found no
difference in growth between children taking their drugs and
those taking a placebo. Other experts noted that asthma itself
appears to cause a slowdown in growth, causing further confusion
on the issue.
The corticosteroids and the newer drugs such as Merck's
Singulair and Zeneca's Accolate aren't intended as a treatment
for an asthma attack. Patients should still use quick-relief
medications for those.
Currently, most patients use inhalers, which dispense
medications in short blasts, to treat breathing attacks
associated with asthma. Glaxo, Schering-Plough Corp. and
Minnesota, Mining and Manufacturing Co. are among the companies
that make and sell the inhalers.
The U.S. market for asthma drugs is expected to grow to as
much as $2.38 billion in 2005 from $1.18 billion in 1996.
--Kristin Jensen in Bethesda, Maryland through the Washington |
