The purpose of this note is to address a recent concern brought up in the newspaper.  The article is concerning the use of Advair for the control of asthma.  The article states that the FDA is asking the drug manufacturer to include a warning that using medications like Advair, Serevent, or Foradil could increase the chance of severe asthma attacks, some resulting in “death”.

I’d like to explain what is going on.  Each of these medications contains a “Long Acting Beta Adrenergics” (aka long acting Albuterol type of medications).  The concern is that using these long acting medications could “mask” increasing asthma symptoms until they become severe and difficult to treat.  The current recommendations are that these “Long Acting Beta Adrenergics” be used in combination with other medications to control the ongoing symptoms of asthma.  These “other medications” include the anti-inflammatory medications such as the inhaled steroid medications (Pulmicort, Flovent…) and/or Singulair.  Also, these “Long Acting Beta Adrenergics” should be added only when the anti-inflammatory medications alone are not enough to control the Asthma.  Our goal has always been to use the fewest medications needed to control the Asthma, while having those medications have the best effects and the fewest side effects.  This means that most of you are on one of the “Long Acting Beta Adrenergics” because they are required to control your asthma.

The take home point is as follows:

1.       Do not stop or change your medications without checking with us first.  In most cases you are on those medications for a reason and stopping them may result in an asthma attack.

2.       The “Long Acting Beta Adrenergics” are NOT rescue medications.  They are meant as every day controllers.  If you are having trouble with your asthma, use your rescue medication (albuterol), not the Advair/Serevent/Foradil.

3.       The purpose of your regular check ups is to make sure you are on the best medication plans.  In order to make sure you are on the best plan you must keep your regular visits, even if you are feeling well.  An ounce of prevention is worth a pound of cure.

I hope that this answers most of your questions regarding the recent newspaper articles.  If you have any other concerns, please contact my office.

For those of you who want to see the actual FDA information, I have printed it below:

FDA ALERT [11/2005] In some patients with asthma, medicines called “long-acting beta-agonists” (LABA) may increase the chance of death from asthma problems.

FDA has asked companies that make products containing long-acting beta-agonists, including Advair Diskus, to give special warnings to healthcare professionals and patients about these possible risks.

Because LABAs, such as Advair Diskus, may increase the chance of asthma death in some people:

• Advair Diskus should not be the first medicine you use for asthma.
• Advair Diskus should only be used if an inhaled corticosteroid along with once in a while use of a short-acting bronchodilator medicine does not control your asthma.

This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

What Is Advair?

Advair Diskus contains 2 medicines:

• Fluticasone propionate, an inhaled corticosteroid medicine. Inhaled corticosteroids help to decrease inflammation in the lungs.  Inflammation in the lungs can lead to asthma symptoms. 

• Salmeterol inhalation powder, a long-acting beta-agonist (LABA) medicine.  LABAs help to relax the muscles around the airways in your lungs.  Wheezing happens when the muscles around the airways tighten.   This makes it hard to breathe.   In severe cases, wheezing can stop your breathing and cause death if not treated right away. 

Advair Diskus does NOT relieve sudden breathing problems. Always have a short-acting bronchodilator medicine with you to treat sudden breathing problems.

Advair Diskus is used for:

Asthma

• Advair Diskus is used long-term, twice-a-day, to control symptoms of asthma in adults and children ages 4 and older.

Advair Diskus is not for adults and children whose asthma is well controlled with:

• an inhaled corticosteroid alone
• an inhaled corticosteroid along with once in a while use of a short-acting bronchodilator

Chronic Obstructive Pulmonary Disease (COPD)
Advair Diskus is used long-term, twice-a-day in controlling breathing problems in adults with COPD with chronic bronchitis.

What Are The Risks?

The following are the major potential risks and side effects of Advair Diskus therapy. However, this list is not complete.

Advair Diskus may worsen your breathing problems.  See FDA Alert.

Other possible side effects with Advair Diskus include:

• immune system effect and a higher chance for infections
• lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
• eye problems including glaucoma and cataracts. You should have regular eye exams while using Advair.
• slowed growth in children
• increased blood pressure
• fast and irregular heartbeat
• allergic reactions including, rash, hives, and swelling of the face, mouth, and tongue
• headache
• tremor
• nervousness
• throat irritation

Tell your healthcare professional about any side effect that bothers you or that does not go away.

What Should I Tell My Healthcare Professional?

Before you start using Advair Diskus, tell your healthcare professional if you:

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have osteoporosis
• have an immune system problem
• are pregnant or planning to become pregnant.  It is not known if Advair may harm your unborn baby.
• are breastfeeding.  It is not known if Advair passes into your milk and if it can harm your baby.

Can Other Medicines or Food Affect Advair?

Advair Diskus and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Some medicines may affect how Advair works or Advair may affect how your other medicines work.  Especially tell your healthcare professional if you take ritonavir. The anti-HIV medicines Norvir and Kaletra contain ritonavir.

Know the medicines you take. Keep a list of them with you to show your healthcare professional.

How Do I Use Advair?

Read the step-by-step instructions for “How to Use Advair” that comes with the medicine.  Do not use Advair Diskus unless your healthcare professional has taught you and you understand everything. 

• Use Advair exactly as prescribed.  Do not use Advair Diskus more often than prescribed.
• Do not use a spacer device with Advair Diskus. Do not breathe into the Diskus inhaler.
• Do not change or stop any of your medicines to control or treat your breathing problems.  Your healthcare professional will adjust your medicines as needed. 
• Make sure you always have a short-acting bronchodilator medicine with you.  Use your short-acting bronchodilator if you have breathing problems between doses of Advair. 

Call your healthcare professional right away if:

•  your breathing problems worsen while you are taking  Advair Diskus
• you need to use your short-acting bronchodilator more often
• your short-acting bronchodilator does not work as well for you at relieving symptoms
• you need to use 4 or more inhalations of your short-acting bronchodilator for 2 or more days in a row
• you use 1 whole canister of your short-acting bronchodilator medicine in less than 8 weeks time

Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-4570