Recently, millions of asthma patients have begun taking long-acting drugs to allow them to breathe a bit more normally, which allow them to experience continual sleep in the evenings or workouts at the gym.
At the moment, the Food and Drug Administration is examining if these medications could increase the risk of severe asthma problems.
At a meeting on Wednesday, independent medical advisers will review the scientific facts and make a decision on if the drugs should continue to be used in treating asthma.
Under discussion are four inhaler medications: Advair, Foradil, Serevent and Symbicort. The safety office advises that Foradil and Serevent should not be used for asthma, and none of the drugs be taken by children 17 and under.
However, the head of the FDA office that supervises respiratory medications has announced that prohibition of the drugs would be “an extreme approach,” and will backfire by causing additional cases of uncontrolled asthma.
The companies that manufacture the medications insist that they are not dangerous, and that the medical evidence being used by the FDA is weak. Doctors who take care of asthma patients are apprehensive that the drugs may be banned.
“We would lose a medicine that patients find helpful,” said Dr. Paul Greenberger of Northwestern University in Chicago, president-elect of the American Academy of Allergy, Asthma & Immunology. “We would be going backward, and the consequences of that would be more untoward effects of asthma. That’s a major deal, because asthma hospitalizations continue to be too high.”
The four drugs include a long-acting medication called LABA (for “long-acting beta 2-adrenergic agonist”). The drug loosens up constricted muscles around narrowed airways. Medical procedures for treating moderate to severe asthma advise the use of a LABA along with a steroid, which targets the inflammation around the airways.
Foradil and Serevent are LABA-only products. Advair and Symbicort merge a LABA and a steroid together in one inhaler that patients employ every 12 hours. Asthma patients should also have a “rescue” inhaler to treat with the unexpected onset of symptoms.
On the agenda for the meeting is the reviewing of the findings from 110 clinical trials concerning 61,000 patients, which compares patients who took a medication that had a LABA with those who only used a steroid to treat their asthma. Experts were on the lookout for deaths, hospitalizations and instances where a patient had to have a breathing tube inserted.
The investigation located 20 deaths from asthma complications, of which 16 were taking a LABA-only medication, Serevent.
Approximately 22 million people in the United States have asthma, and children account for one out of every three patients. Asthma kills 3,600 people annually in the U.S.
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