Can Advair cause death in asthmatics?

My short answer is NO. I was asked this because a mom brought in an article from the June 2008 issue of Men’s Health magazine (page 125). The article was titled “8 drugs doctors would never take.” The first medication was Advair. I found the wording of the article potentially misleading. Advair contains two compounds: fluticasone propionate (a corticosteriod) and salmeterol (a long-acting bronchodilating agent (LABA)). The latter was associated with a statistically significant increase of death from asthma in blacks in 2 large studies performed in the United Kingdom and the United States. There were several possible explanations given for these results, but none were definitive. The U.S. F.D.A. responded to this finding by placing black box warning on all available LABA compounds that are sold in the U.S. They also asked for trials to be done specifically to address this question: do blacks have a higher rate of adverse effects from LABAs, such as death or respiratory events? Both GlaxoSmithKline, the manufacturer of Advair, and AstraZeneca, the manufacturer of Symbicort, are working on separate trials to answer this question, because the two products mentioned are the two available combination corticosteriod-LABA products sold in the U.S. today. Other companies selling LABAs must do studies also. I agree with the FDA’s request for further information. Other studies around the world have not noted this result and I find this very reassuring.

An article titled “Meta-analysis: Effects of Adding Salmeterol to Inhaled Corticosteroids on Serious Asthma-Related Events” in the Annals of Internal Medicine 2008 July 1 [http://www.annals.org/cgi/content/abstract/0000605-200807010-00229v1] authored by Bateman E, et al. examined 20,966 patients from 66 trials. They concluded “Salmeterol combined with inhaled corticosteroids decreases the risk for severe exacerbations, does not seem to alter the risk for asthma-related hospitalizations, and may not alter the risk for asthma-related deaths or intubations compared with inhaled corticosteroids alone.” There was no increased risk of death or adverse events found. Two other articles preceded this. One was “Long-acting beta-agonists in adult asthma: Evidence that these drugs are safe” by Harold Nelson in 2006. The other was “Safety and effectiveness of long-acting inhaled beta-agonist bronchodilators when taken with inhaled corticosteroids” by Pierce Ernst and others in Canada also in 2006. These were reassuring to me and I hope to patients who take either of these combination asthma products. I do not hesitate to prescribe these products and I monitor their asthma and body with routine followup visits, as recommended by every published guideline for the diagnosis and treatment of asthma. (To read more about LABAs, check other posts.)

[An aside, for those with chronic obstructive pulmonary disease (COPD) and using a combination corticosteroid-LABA inhaler. Question: is this medication associated with high adverse outcomes in those with COPD (which is similar to asthma)? I searched PubMed, the National Library of Medicine"s database, and found this recently published article by Rodigo et al titled "Safety of long-acting beta-agonists in stable COPD: a systematic review."
http://www.ncbi.nlm.nih.gov/pubmed/18460518?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum There was no increased risk of deaths. Again, I am reassured.]

I want to comment on three other drugs mentioned by the article. I agree with the article about Ketek (an antibiotic) and O.T.C. Visine Original eye drops. I would try to avoid taking these medications. Finally, the dangers from pseudoephredrine are exaggerated, although the point of trying to avoid it in patients with heart disease or hypertension is well stated. I do try hard to do this.

The article’s and my suggestion is to get used to rinsing your nasal passages routinely with saline solution or just plain water. I rinse my nasal passages at least four times daily. Why? Because I consider it good nasal and sinus hygiene, since I am exposed to sick patients every day. In short, whatever they have, I do not want it. Remember some infections are spread through the air. So I rinse my nose just like I wash my hands. Both steps work great to reduce the chances of my getting an infection and my spreading infections.

If you have questions about your asthma medications, ask your doctor.