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.

Taking Your Sinuses to the Desert

Sinusitis in a Desert Environment
Living in Phoenix presents unique problems for the sinuses.  The sinuses need a constant flow of mucous to stay healthy.  Individuals who grew up in a humid environment like Chicago, Portland, or Atlanta and then move to Ahwatukee, Chandler, or Maricopa, may suddenly find that the dry climate of their new home does not provide enough moisture to keep the sinuses functioning as usual.

Like the excessive tearing associated with chronic dry eyes, the sinuses may respond to the dry conditions by producing too much mucous, leading to post nasal drip syndrome, the nagging sensation of mucous in the the back of the throat  frequent throat clearing, and cough.  In addition, the amount of suspended fine particles in the air such as quartz and diesel particles, is greater in the desert, and when breathed can damage the lining of the  nose,  sinuses, and airways leading to tissue injury and chronic inflammation.   The inflaming effect of particulates and other air pollutants may heighten the effect of  air-born pollen and mold.  The result if more severe allergies, asthma, and sinus problems.

Mistaken asthma

There is a common saying among doctors that treat asthma: “Not all that wheezes is asthma and not all asthma wheezes”.   This is to remind us to be on the look out for conditions that look like asthma but may not be.

One of the most common asthma mimickers is a condition known as vocal chord dysfunction.  When we speak or sing, the vocal chords tighten and vibrate as a small about of air passes through the narrow opening.   The vocal cords are relaxed during normal breathing, allowing air to easily pass through the trachea.  In a condition called vocal cord dysfunction, the vocal cords and surrounding structures close together, or constrict, during one or both parts of the breathing cycle, partially blocking the windpipe and creating a sensation of not getting enough air.   The symptoms of vocal chord dysfunction are very similar to asthma: shortness of breath, chest tightness, and wheezing.  In fact, patients with vocal chord dysfunction are frequently treated with strong asthma medications including steroids for years before the proper diagnosis is made.

So what causes the vocal cords to tighten during normal breathing?  In many, vocal cord dysfunction is a type of involuntary stress reaction.  The vocal cords tighten during periods of stress.  This may be the case even though an individual does not feel particularly stressed or anxious. Vocal cord dysfunction had recently been recognized a frequent cause of exercise induced shortness of breath, particularly in children involved in school sports.  A child, who has a strong internal drive to win or feels pressure from a coach or parents to do better, may exhibit vocal chord problems.

The most important step in managing vocal chord dysfunction is suspecting it in the first place, particularly in someone who has been diagnosed and treated for asthma but is not responding to typical medications.    Effective treatment includes education and speech therapy.

When A Little Knowledge Can Be A Dangerous Thing

Food Allergy Blood Tests

Many parents are aware of the dangers of food allergies, however food allergy researchers are suggesting that strictly avoiding foods based on the results of an allergy test can make the problem worse.

Food allergy is common in young children. Just how common is unclear.  A recent report  in the Journal of Allergy and Clinical Immunology cited a review of over fifty studies  from around the world evaluating the prevalence of food allergy.   The result showed a disturbingly wide range of values with the frequency of milk allergy ranging from 1.2% to 17%, 0.2% to 7% for egg, 0% to 2% for peanut and fish, 0% to 10% for shellfish, and 3% to 35% for any food. Read more