Thursday, December 22, 2005

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
NEWSPAPER ARTICLE
Dreading spring
April, 2003

While her friends are excitedly looking forward to the arrival of spring, Rachel dreads the springtime. Spring brings her misery during which she suffers from annoying fits of sneezing. Nasal congestion, which worsens at nighttime, does not allow restful sleep. She is miserable from itching in the nose, roof of the mouth, and throat. Her eyes itch and water. No wonder she is not looking forward to springtime.

Rachel is suffering from hayfever. Hayfever is a misnomer because patients do not develop fever. The medical name for hayfever is allergic rhinitis. Typically, Rachel’s symptoms start in March. In some years, her symptoms start in late February.

Frustrated, Rachel asked, “What is in the air?” During spring, pollens of trees cause allergic symptoms. In our region pollens of Rocky Mountain Juniper, Cottonwood, American and Chinese Elm, Ash, etc., are the culprits. Chopping them down is not the solution as their pollens float into the air and can get carried away by wind for miles.

“Dr. Patel, what time of day should I not venture outdoors?” Rachel inquired. Besides closing the windows and turning an air conditioning on in the house and car, I do not recommended drastic lifestyle altering measures because they are not practical and most are minimally effective. With modern treatment programs, doctors can relieve the suffering.

“Initially, for the first few days, Claritin, which I purchased over the counter, seemed to help somewhat; but, it doesn’t work anymore,” Rachel reported. Now Claritin, an antihistamine, has become over the counter; of course, it is fairly expensive. Antihistamines, as a group, have been around for many years; names such as Benadryl, Chlor-Trimeton, Tavist-1 and many others are very familiar

Oral antihistamines may reduce sneezing, itching, and runny nose in addition to watery, itchy eyes. Typically, antihistamines do not help nasal congestion. So, pharmaceutical companies combined antihistamines with oral decongestants such as pseudoephedrine -- Sudafed being the popular brand name.

Older antihistamines such as Benadryl and Tavist are sedating and may affect cognitive and motor function, even without obvious sedation. Newer antihistamines such as Claritin, Clarinex, and Allegra are non-sedating.

Antihistamines may cause bladder retention in persons with enlarged prostate.

With the availability of Claritin over the counter, some insurance companies are asking patients to try Claritin first before approving other antihistamines such as Allegra, Clarinex, or Zyrtec. Some insurance companies are asking patients to pay substantially high co-pays for prescription antihistamines.

“Dr. Patel, should I try something else over the counter? I cannot decide what to choose, as a plethora of products are available over the counter for treatment of nasal and sinus symptoms,” Rachel inquired.

Grouping the available over-the-counter medications as follows will help in the selection of appropriate medication:

Pure antihistamine
a. Over-the-counter:
Benadryl, Tavist-1, Claritin and many others.
b. Prescription:
Allegra, Clarinex, Zyrtec and others.

Pure oral decongestants such as pseudoephedrine, Sudafed, and phenylephrine. Patients with high blood pressure should check with their doctors before using oral decongestants.

Combination of oral antihistamine and decongestant such as Allegra-D, Claritin-D, Zyrtec-D and others.

Addition of acetaminophen, Tylenol, to antihistamine and decongestant. For example, Dimetapp Cold and Allergy Tablets contain acetaminophen, a pain reliever, chlorophenamine, an antihistamine, and phenylephrine, a decongestant.

Guaifenesin is supposed to help with mucous, and drug companies combine it with antihistamines and/or decongestants. For example, Dimetapp Cold and Congestion Caplets contain dextromethorphan, a supposed cough suppressant, guaifenesin, supposedly an expectorant, and pseudoephedrine, a nasal decongestant.

Dextromethorphan: Companies add it to combination products to reduce the cough. I am not sure how much dextromethorphan helps the cough.

As I am discussing, antihistamines let me mention an intranasal antihistamine, Astelin, which is available only by prescription. It can cause sedation in some and has an unpleasant taste.

Of course, many more options are available for treatment of hayfever. In future columns, I will address cortisone nasal sprays and the role of a leukotrine modifier, Singulair, which has been recently approved for treatment of allergic rhinitis.

By the way, cromolyn, NasalCrom, is available over the counter. NasalCrom may help mild hayfever symptoms, but a patient has to use it 4-6 times per day for it to be effective. I, myself, would have difficulty in using a medication 4-6 times a day, every day.

I advise my patients not to use nasal decongestant sprays such as Afrin, which when stopped can cause rebound nasal congestion and eventually are habit-forming.

Ashok Patel, MD, Allergist, Academy Allergy, Asthma, Sinus & Immunology Center