New Advair and Symbicort FDA Warning

This week the FDA announced their recommendations for label changes for products containing long-acting-beta-agonists (LABAs). Long-acting-beta-agonists are found in Advair and Symbicort, two of the most widely prescribed asthma medications in the US and Europe.

The specific label changes recommended by the FDA for Long-Acting Beta-Agonists (LABAs) include:

1. Contraindicate the use of LABAs for asthma in patients of all ages without concomitant use of an asthma-controller medication such as an inhaled corticosteroid.

2. Stop use of the LABA, if possible, once asthma control is achieved and maintain the use of an asthma-controller medication, such as an inhaled corticosteroid.

3. Recommend against LABA use in patients whose asthma is adequately controlled with a low- or medium-dose inhaled corticosteroid.

4. Recommend that a fixed-dose combination product containing a LABA and an inhaled corticosteroid be used to ensure compliance with concomitant therapy in pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid.

Some background and a few thoughts.

A number of large studies conducted over the past 20 years have suggested that there is an increased risk of severe asthma attacks associated with the use of the  long-acting-beta-agonists salmederol and fermoderal.  Salmederol is found in Advair and Fermoderal is found in Symbicort.

Unfortunately, it has not been possible to determine if the patients in the study who had severe attacks were also taking an inhaled corticosteroid at the time. This fact is very important.

Most asthma specialists would predict that, for patients with moderate to severe asthma, using a long-acting-bronchodilator alone  without using a daily anti-inflammatory medication, could cause  problem.    An analogy would be taking an antibiotic and Ibuprofen for pneumonia. Both medications are used to treat pneumonia.  However, if you were given both medications but only took the Ibuprofen, for a time you would feel better with less fever, body aches, and chest pain.  Without antibiotics, however the infection in the lungs could continue to worsen, even to the point were antibiotics would no longer save the patient. In asthma, steroids control the inflammation in the airways which is at the heart of asthma symptoms. Short and long-acting bronchodilators temporarily relieve the chest tightness, cough, shortness of breath and wheezing of asthma but have no effect on the inflammation.  This can lead to a serious, even fatal asthma attack. In the pneumonia analogy it would be short sighted to blame the use of Ibuprofen for a death caused by pneumonia: it has never been  good practice to treat the symptoms of pneumonia alone without addressing the infection, and a poor outcome would be expected. A poor outcome is also to be expected from an asthma treatment that masks the seriousness of the condition by providing temporary relief of symptoms without addressing the dangers of progressive inflammation.   It is possible that the results of the studies that have concerned the  FDA confirm what has always been assumed:  Daily symptom relief medications should not be used without the concurrent use of effective anti-inflammatory agents such as inhaled corticosteroids.   This is not a problem with Advair and Symbicort, both of which contain inhaled steroids.