A Food and Drug Administration panel of medical
experts is weighing whether to allow certain asthma drugs to be marketed for
the treatment of asthma amid concerns of side effects. One federal drug official
strongly recommended that the commonly prescribed asthma drugs Serevent,
Symbicort, and Foradil no longer be used to treat asthma in adults or children because
they have serious side effects and they may increase the risk of asthma-related
deaths.
Clinical trials have shown that patients
taking Serevent, Symbicort, or Foradil have a small increased risk of asthma-related
hospitalization. Serevent is a combination of an inhaled corticosteroid and the
long-acting beta agonist (LABA) Serevent. Serevent and Advair are both used to
prevent exacerbation of asthma by relaxing the airways. The medications already
carry strong government warnings. The labels of Serevent and Foradil mention
that doctors should prescribe them along with steroids. The problem is that
only a half of patients who take the medicines also get a prescription for
steroids.
In their two-day joint meeting, which is
scheduled for Dec.10-11, the panel will review the findings from 110 clinical
trials involving 61,000 patients, which compares patients who took an asthma-medication
that contained a long-acting medication called LABA (for “long-acting beta
2-adrenergic agonist”) with those who only used a steroid as treatment for
their asthma. The analysis, which looked for deaths, hospitalizations and cases
in which patients had to have a breathing tube inserted, has found 20 deaths
from asthma complications. Of these, 16 were in patients taking LABA-only drug,
Serevent.
The medications were approved for children
in 2006 in the U.S.
Two years ago the agency advised consumers to limit the use of the drugs to
patients who do not benefit from other similar medication following a study
which showed chances of asthma-related deaths among Serevent users increased with
400 percent.
The FDA’s drug-safety officials recommended
that the drugs no longer be given to children 17 and under who suffer from
asthma, but split on whether the drugs should be banned for adults.
On the other hand, the companies that
manufacture the drugs insist that they are not dangerous, and that there isn’t enough
evidence to justify the prohibition of the drugs.
Asthma is a chronic respiratory disease
which causes inflammation and narrowing of airways in the lung. The airways
occasionally constrict, become inflamed, and are lined with excessive amounts
of mucus, often as a response to one or more triggers, such as exposure to an
environmental stimulant (e.g. an allergen, environmental tobacco smoke, cold or
warm air, perfume, pet dander, moist air) or even emotional stress. Medication
can help control the disease and relieve pressure in the airways during an
asthmatic episode.
According to the National Institutes of
Health, almost one in ten Americans is diagnosed with asthma at some time. The
number of children with asthma has more than doubled since the 1980s. According
to the CDC estimates, about 20 million Americans have asthma, including 9
million children.