FDA official’s criticism of Severent is only partially right
By ASHOK PATEL, MD

Are you confused when a prominent doctor from the FDA alleges that five drugs are dangerous to your health, while another doctor speaking on behalf of the FDA rejects the allegations as hysterical?

Recently, during his testimony in the Senate, Dr. David Graham, associate science director of the Office of Drug Safety at the Food and Drug Administration, alleged that Accutane, Meridia, Bextra, Crestor and Serevent might not be safe to take.

Dr. Graham is right on the mark regarding concerns on Serevent (salmeterol), but in my humble opinion, only partially. How? To understand the issue, first you have to know what goes wrong in asthma. In simple terms, in asthma the bronchial tubes are in spasm and inflamed. To relieve the spasm or constriction of bronchial tubes, doctors prescribe bronchodilator medications, which dilate the bronchial tubes. You may be familiar with a very widely used bronchodilator - albuterol, also available as Proventil and Ventolin brands. The bronchodilator effect typically lasts for 4-6 hours. Albuterol is a short-acting bronchodilator.

To prolong the bronchodilating effect, pharmaceutical companies developed long-acting bronchodilators, two of them are salmeterol (Serevent) and formoterol (Foradil). If doctors prescribe only bronchodilators, they are correcting only one part of the problem, bronchoconstriction. To heal the inflammation, they have to prescribe anti-inflammatory medications. The mainstay anti-inflammatory medications for chronic use are inhaled glucocorticosteroids. Some of the commonly used ones are:

1. Flovent Inhaler (fluticasone).
2. Pulmicort Inhaler (budesonide).
3. QVAR, Beclovent, Vanceril, (beclomethasone).
4. AeroBid (flunisolide).
5. Azmacort (triamcinolone).

Patients with asthma should definitely be taking an anti-inflammatory inhaler and possibly a long-acting bronchodilator. Why? Numerous studies have shown that when doctors combine an anti-inflammatory inhaler and a long-acting bronchodilator, the asthma is much better controlled. No wonder GlaxoSmithKline (GSK) came out with a combination product, Advair - a combination of fluticasone, an anti-inflammatory medication, and Serevent Inhaler, a long-acting bronchodilator. Tens of thousands of doctors prescribe Advair everyday, and millions of patients love it to control their asthma. As far as I know, nobody has raised a safety alarm for Advair Inhaler, even though it contains Serevent. Why? When patients are using Advair, they are addressing the two components of asthma - bronchoconstriction and inflammation.

On the other side of the coin, when they are using only a Serevent Inhaler, the inflammation keeps simmering, their asthma gradually worsens, and they may suffer a bad outcome. The bad outcome is not the side effect of a Serevent Inhaler but the consequence of unchecked inflammation, which the doctor has not addressed with anti-inflammatory medication.

Consequently, I do not recommend my patients use a Serevent Inhaler by itself. The silver lining of the controversy is patients and doctors will review their use of Serevent. If they are using only Serevent, in my opinion, they shall consider adding an anti-inflammatory medication.

As an allergist, I have extensively studied Serevent. Not only am I extremely familiar with it, but also I have done consulting work for GSK. Even though you may consider me GSK’s hired gun, you will find the information herein valuable and helpful.

Based on my observations on how GSK has acted in our region, I give credit to GSK for promoting the correct use of a Serevent Inhaler.
The FDA has also approved Serevent for COPD. Unfortunately, we do not have a magic cure for COPD. Almost all doctors recommend stop smoking, stop smoking, stop smoking! If your doctor has recommended you supplemental oxygen because your oxygen saturation is less than 88 percent, don’t be bashful, use the oxygen as per your doctor’s advice. Besides stopping smoking and supplemental oxygen, doctors recommend numerous medications and measures, most of which I consider just a Band-Aid.

If you are concerned about the safety of Serevent, your doctor may change Serevent to another bronchodilator, or he may substitute Advair in place of Serevent. Why? Some COPD patients benefit from the anti-inflammatory medication. As said above, Advair contains both - an inhaled corticosteroid and a bronchodilator. By the way, the FDA has approved Advair 250/50 mcg 1 puff twice a day for the treatment of COPD.

As there is a widespread steroid phobia, in my opinion, to discuss the side effects of inhaled corticosteroids will require another lecture. I feel at home in delivering another lecture as I have extensive experience with inhaled corticosteroids. In the past 16 years, like legions of other doctors, I have prescribed thousands of patients inhaled corticosteroids. Like "McDonald's", pharmaceutical companies marketing inhaled corticosteroids can have a slogan “More than _______ millions served.”

Ashok Patel, M.D., Allergist, Academy Allergy, Asthma, Sinus & Immunology Center