Asthma Drug Combo Could Be Dangerous
Long-Acting Beta Agonist and Inhaled Steroid Sometimes Have Negative Side Effects
Aug. 24, 2006 -- Medications used for long-term control of asthmaasthma -- known as long-acting beta agonists -- are among the most widely prescribed asthma medications. But now there are new concerns that too many patients are taking them.
Drugs such as Advair, Serevent, and Foradil are beta-agonist bronchodilators that are used to relax smooth muscles in the airways. Late last year, the FDA announced that the packaging for these drugs would have to carry new 'black box' warnings that the medications may increase the risk of severe, potentially life-threatening asthma flares in some people.
The regulatory agency also recommended that use of the drugs be restricted to patients whose asthma is not adequately controlled with inhaled corticosteroids alone -- the cornerstone of asthma-control therapy.
But long-acting beta agonists (LABA) are still aggressively marketed to both the public and primary care doctors who are often unaware of the safety concerns, asthma specialist Miles Weinberger, MD, tells WebMD.
"These drugs are being used too much and patients who are on them are often not monitored as they should be," he says.
Advair and Serevent, both manufactured by GlaxoSmithKline, contain the active ingredient salmeterol. In a study funded by the drug company, asthma-related deaths were slightly more common in patients on salmeterol than among patients on a placebo. GlaxoSmithKline is a WebMD sponsor.
The overall number of asthma deaths was small, however, with 13 deaths among 13,176 patients who took salmeterol for seven months. But the findings led to the FDA action.
Side Effects of Drug Combo
Writing in today's New England Journal of Medicine, Weinberger and colleague Mutasim Abu-Hasan, MD, reported on two of their own patients with severe asthmaasthma who had life-threatening reactions on a combination treatment with a long-acting bronchodilator and an inhaled steroid.
Both patients were adolescent boys who were admitted to the Children's Hospital of Iowa following severe asthma attacks while on the combination treatment.
Treadmill exercise tests revealed that both patients experienced profound constriction of their airways within minutes of beginning exercise while on the combination therapy, despite pretreatment with the inhaler medication albuterol. This short-acting beta-agonist medication is used prior to exercise to prevent exercise-induced symptoms and provides quick relief of asthma symptoms.
When the long-acting asthma medication was replaced with another asthma treatment, the boys' asthma control improved, as did their response to the medications used to treat an acute attack -- or quick relief therapy.
Weinberger says most patients whose asthma cannot be controlled with a low-dose inhaled steroid do benefit from adding a long-acting bronchodilator to their daily maintenance treatment.
But he adds that it is increasingly clear that there is a small subgroup of patients for whom the combination treatment has a negative, rather than positive, effect.
"We do not want to unduly alarm people but instead help spread the word that patients should talk to their physicians if they are using Advair, or another inhaled asthma medication that contains salmeterol, and feel that it worsens symptoms instead of making them better," he says.