Medications for the Treatment of Asthma - Are They Safe and Effective?

A number of products that block the histamine receptor (anti-histamines) have been developed to treat the allergies that trigger attacks in those suffering from atopic asthma attacks. These include hydroxyzine (Atarax, Vistaril) and its breakdown product cetirizine (Zyrtec). These medications cause sleepiness. Other side effects include dry mouth and urinary retention, and more rarely, confusion, nightmares, nervousness, and irritability. Chlorpheniramine (Chlor-trimeton), cyproheptadine (Periactin), and diphenhydramine (Benadryl) are other older antihistamines. They can be associated with anti-cholinergic side effects (dry mouth, confusion, urinary retention), in addition to the side effects of Atarax.

The so-called second-generation antihistamines supposedly cause less drowsiness than the older products, but this is more hype than hope. They claim to specifically block the H-1 antihistamine receptor, and include fexofenadine (Allegra), loratadine (Claratin), and azelastine (Astelin). Side effects are similar to the older antihistamines. Drowsiness with all of the antihistamines is dose dependent. It is best to start with a low dose and work up.

One of the best selling allergy medications on the market is desloratadine (Clarinex). Clarinex is a newer generation anti-histamine medication that is marketed as a magic bullet for allergies. However what most people don't know is that Clarinex is merely an old drug, loratadine (Claritin), marketed by the drug company as new and improved. However Clarinex doesn't add anything to Claritin (other than more money for the coffers of its manufacturer, since Clarinex is still on patent). Clarinex is merely a metabolite (breakdown product) of its precursor, Claritin. That means that 20 minutes after you take Claritin, you will be getting Clarinex, but you'll be paying much less for it than if you took Clarinex. Folks have been getting Clarinex for years, even though they didn't know it, every time they took Claritin. The company patented the metabolite of their original product, and then did a misleading study where they compared differing doses of the two medications, coming to the erroneous conclusion that Clarinex was less sedating than the old drug. This was misleading because if a drug causes sedation, then higher doses of the drug will cause more sedation, so if you are not comparing the same doses of the drug, you are not making a fair comparison. This allowed them to promote Clarinex, which costs much more than the old drug that went off patent, and which in 2004 was bringing in close to a billion dollars a year in sales. Claritin and Clarinex as far as you are concerned are the same drug; so take Claritin and save some money.

Over the counter (OTC) epinephrine inhalers such as Primatene Mist are commonly used for the treatment of mild asthma. Over 115 million Primatene Mist inhalers have been sold over the past 20 years. These inhalers, however, are not as benign as they appear. About 20% of patients using OTC inhalers have severe asthma that needs medical care. Unfortunately, many asthma patients delay professional medical treatment while they use their OTC inhalers, often due to a lack of health insurance, to the point where it may be too late. OTC inhalers can also increase heart rate, and should not be used in patients with heart or thyroid disease. Thirteen deaths, mostly cardiovascular, have been reported to be associated with the use of OTC inhalers over the last 20 years. If you have a history of chronic asthma or a history of hospitalization for asthma you should not use OTC inhalers. If asthma symptoms do not resolve in 20 minutes after using an OTC inhaler, you should seek emergency treatment. Delaying medical treatment when you are using OTC inhalers may contribute to the overall severity and chronic nature of the disease over the lifetime.

Prescription short acting bronchodilators (�-2 agonists) are inhaled and promote dilation of airways. The most commonly prescribed inhalers are albuterol (Proventil) and levalbuterol (Xopenex). Side effects include tremors, jitters, and nervousness. There are no known long-term side effects. These medications are designed for temporary relief. If you find yourself using them often or with increasing frequency that means your asthma is getting worse and you need further evaluation by a doctor.

Asthma patients can also be treated with steroids in pill form for a short period of time. Corticosteroids can inhibit growth in children and decrease bone mineral density, although growth inhibition is reversible. Steroids suppress the immune response, increasing risk of infection, and decrease bone mineral density. Other side effects of steroids include low blood sugar, changes in consciousness, nauseas, seizures, or in rare cases death. You can also develop symptoms like Cushing's Disease (an excess production of cortisol in the body). These include deposits of fat on the upper back and face, high blood pressure, diabetes, slow wound healing, osteoporosis, cataracts, acne, muscle weakness, ulcers, thinning of the skin, and mood changes. When patients are treated for a long period of time, deaths from adrenal insufficiency have occurred with transfer from oral to inhalation steroids, especially during stressors like surgery. You should not be on steroids for long periods of time.

Non-allergic asthma is a chronic problem, and needs to be treated somewhat differently than allergic asthma, which may come and go with avoidable triggers and seasonal changes. Chronic asthma sufferers are more at risk for fatalities if they are not treated.

Corticosteroids

Patients with chronic asthma should be treated with inhaled corticosteroids. These include fluticasone (Flonase, Flovent), beclomethasone (Qvar, Beconase, Vancenase), flunisolide (Aerobid), budesonide (Rhinocort, Pulmicort), and triamcinolone (Azmacort, Nasacort). Inhaled corticosteroids have the same side effects of systemic steroids, but to a much lesser degree. Corticosteroids can inhibit growth in children and decrease bone mineral density, although growth inhibition is reversible. Steroids suppress the immune response, increasing risk of infection, and decrease bone mineral density. Other side effects of steroids include low blood sugar, changes in consciousness, nauseas, seizures, or in rare cases death. You can also develop symptoms like Cushing's Disease (an excess production of cortisol in the body). These include deposits of fat on the upper back and face, high blood pressure, diabetes, slow wound healing, osteoporosis, cataracts, acne, muscle weakness, ulcers, thinning of the skin, and mood changes. Studies have shown that inhaled corticosteroids (budesonide) can be used intermittently; there is no advantage to regular use of these medications.

Theophylline (theodur, slophyllin) and the related aminophylline drugs are xanthine derivatives related to caffeine that act to dilate the bronchi. Aminophylline can cause rash in some people. They can be given either orally or intravenously for asthma emergencies. Toxicity results in seizures, irregular heartbeats, and pounding heartbeat. It interacts with ciprofloxacine and the other fluoroquinolone antibiotics (i.e. those ending with -xacine) as well as caffeine. They are not used much any more due to safety concerns and side effects.

Long acting beta-2 agonists have been promoted as reducing the need for inhaled quick relief medication. Drugs on the market include salmeterol (Serevent) and formoterol (Foradil). Serevent, approved in 1994, dilates breathing passages by stimulating the beta-2 adrenergic receptor. At least 300,000 children take this drug.

Serevent was isolated as one of five dangerous drugs still on the market by Dr. David Graham of the FDA in testimony to congress in November of 2004. In that testimony he described Serevent users "dying while clutching their inhalers."

In 1996, based on reports of paradoxical bronchospasm (a contraction of the breathing airway or bronchus that impairs breathing and can be fatal) with Serevent, the manufacturer undertook a large multi site randomized placebo controlled trial, the Salmeterol Multi-center Asthma Research Trial (SMART). This was a 28-week safety study comparing salmeterol (Serevent) and placebo in the treatment of asthma.115 In addition to their usual asthma therapy, patients received either Serevent or a placebo. The study was stopped in 2002 by the study's Data Safety Monitoring Board because of an increase in asthma related deaths. Analysis of 26,355 patients showed statistically significantly higher rates of asthma related deaths (13 versus 3, relative risk greater than four fold) in patients on Serevent.

In African Americans, who made up 17% of the study population, the study showed a statistically significant greater number of respiratory related deaths and life threatening events. Many had to get intubated, or have a tube put down their throat to let them breath related to respiratory causes (20 versus 5 for placebo, a four fold increase). In addition, there was a more than four fold increase in asthma-related deaths and life threatening respiratory events in patients taking salmeterol compared to those taking placebo. Overall the risk of death from any cause or having a life-threatening event was doubled in African Americans, another finding that was statistically significant. The data suggested that the risks of Serevent were greater in African Americans than in whites. About half of the patients were also taking an inhaled corticosteroid. In those patients not taking an inhaled corticosteroid, there were significantly more asthma-related deaths in all patients taking salmeterol compared to those taking placebo.

The manufacturers of Serevent initially showed data to the FDA that included the results from the 28-week trial plus a 6 month follow up period. The results for this time period were better than the initial 28 weeks alone. However the initial study protocol was for a 28 week trial, and the FDA appropriately requested the 28 week outcomes, which they posted on their web site in 2005. However the potential risks of long-acting beta agonists have long been known.116 A long acting beta agonist drug marketed in New Zealand was associated with an increase in asthma related deaths and was pulled from the market there in 1976. A recent meta analysis (where data from all published studies were combined) looking at trials from the past 20 years involving a total of 33,826 asthma patients treated with long acting beta agonists showed that all drugs in this class are dangerous.116 Overall there was a statistically significant increase in a number of parameters, including an increase in asthma exacerbations requiring hospitalizations by 2.6 fold, increased life threatening exacerbations of asthma by 1.8, and increased risk of asthma related death by 3.5 fold.

Based on these findings, I do not recommend use of a long-acting beta-2-agonist.

Advair, which contains Serevent and a steroid, also carries the same black box warning about increased asthma related deaths. This hasn't stopped it from running up 2 billion dollars in sales per year. Based on the SMART study we cannot conclude that long acting beta agonists when administered with steroids are safe; in studies where 75% of patients were taking a steroid there was still a 2-fold increased risk of asthma related death.

Montelukast (Singulair) and zafirlukast (Accolate) are part of a new generation of asthma medications that are leukotriene antagonists. These medications work by inhibiting the cysteinyl leukotriene CysLT-1 receptor, which is involved in the inflammatory response. In rare cases they may be associated with Churg-Strauss syndrome, which involves inflammation of the blood vessels. Zileuton (Zyflo) can cause lupus and liver toxicity and requires blood to be checked every six months. They are expensive and have not been shown to be more effective than steroids and antihistamines.

Other new drugs are the mast cell stabilizers like nedocromil (Tilade) and omalizumab (Xolair). Xolair is given by injection every 2-4 weeks. These meds have only recently been approved by the FDA, and so we have to adopt a wait and see attitude.

Learn more about hidden risks of prescription medications in 'Before You Take That Pill: Why the Drug Industry May be Bad for Your Health: Risks and Side Effects You Won't Find on the Label of Commonly Prescribed Drugs, Vitamins and Supplements', by researcher and physician J. Douglas Bremner, MD.

Sinusitis - How I Beat It- You Can Too

After two painful sinus operations, I was still coming down with infections. I had to find some real remedy to my sinusitis problem, as I was tired of taking antibiotics and especially tired of the dull, deep headaches every time I had an attack.

Sinus Operations- Try to Avoid

The operations were no fun. After the first one my nose was "packed". This means that in order to stop the bleeding, the ENT specialist/surgeon put a large amount of gauze in my nose, which means that one can only breathe through the mouth for the week or so of recovery time. In other words, swallowing and breathing cannot occur at the same time. This is a good way to lose weight, as one cannot eat much, but it is not a great way to live. At the end of this period, before pulling out the gauze, the doctor said "this will feel like I'm pulling your brains out through your nose". This was the most accurate statement he ever made to me.

Pulling what seemed like 6 feet of moist, sticky gauze out of my nose was an almost surrealistically painful sensation. But I thought, "if my deviated septum is now fixed, at least I can look forward to no sinus infections in the future, or at least a lot fewer of them. I was wrong again, as they started coming back after a few months. I changed ENT specialists since the first one put me through tons of pain for no gain. After a couple of years of treatment with this new doctor, I decided to take his advice and try another operation. Among other therapies, I had allergy shots during that time, even though I only tested positive for minor allergies to a couple of things.

My nose was not "packed" this time, but there was still plenty of pain. Again my hopes for an infection-free future were dashed when they started up again after a few months. So after two operations by two different ENT specialists, I said "enough is enough". For those considering sinus operations to fix things like a deviated septum, here's my considered advice: don't do it. At least try the nasal irrigation recommended by Dr. Murray Grossan which is explained below before you do. One hears about people who have had 5 or 6 sinus operations, and these either don't work, or if they do cause improvement, it doesn't last very long. Some people have told me that a sinus operation "fixed" their problems, but I am skeptical.

Tried Various Approaches for Years

Throughout my years with significant sinus problems, I had read a number of books and tried different products and approaches. One author I read early-on was not very encouraging. He said that certain things aggravated sinus problems, and one should simply stop eating chocolate, cheese and other dairy products. Also, he said that in order to be cured there could simply be no drinking of alcoholic beverages either. Sorry, he said, but that's the way it has to be. For a person who lived in France and who has come to enjoy the excellent wine and numerous cheese varieties, this was awful.

What kind of a life would I have without drinking wine and eating cheese? At that point I did have to stop drinking, as even one glass of wine could be enough to trigger an infection almost every time. After six months of this I got sick of drinking soda and non-alcoholic beer, which tastes pretty bad. In fact I was ridiculed in a restaurant in France when I ordered a Buckler's , which is Heineken's nonalcoholic beer. The French owner asked my why I would order such a ridiculous beverage with his excellent meal, and I explained I had sinus problems. He replied that he bad sinus problems too, and he got headaches every day, but nothing would stop him from drinking red wine! I actually admired his attitude, but the headaches were too painful, and I felt like I was on the search for "Lorenzo's oil", like the father in the movie of the same title that needed a certain rare oil to cure his son.

It was also through this author, an ENT specialist, that I first heard about nasal irrigation, but the system suggested did not work well. He sold a saline solution, but it was too strong and caused a burning sensation in my nose. He suggested a sort of long-nosed pot called a Neti pot to use to pour the solution into each nostril. This approach did not work nearly as well as the system suggested by Dr. Grossan (see below), and I was wrongly convinced that nasal irrigation was not effective. It makes a big difference how the irrigation is done and with what kind of equipment and saline solution.

Dr. Murray Grossan to the Rescue

I thus started doing more research on other books and approaches, and in the course of this I came across a book by Dr. Murray Grossan called "The Sinus Cure- 7 Simple Steps". In a nutshell, Dr. Grossan's system worked. His book contains many technical explanations about sinusitis and how to deal with it. He clearly explains the reasons for the problem and suggests numerous remedies including diet considerations, home environmental improvements like duct cleaning and humidity control, and the most important aspect of the program: pulsating nasal irrigation with a saline solution.

Use a WaterPik and Adaptor

When I first started following Dr. Grossan's advice he suggested using a WaterPik machine, and these have been sold for years as devices to improve gum and dental health. Dr. Grossan simply sold an adaptor and a saline solution, although one can use table salt. Although much more expensive than salt, I find that this saline solution is convenient, works well, and has no preservatives. I usually purchase a dozen containers at a time, and these will last up to a year with one application per day. One simply puts a spoonful of saline solution into the WaterPik tank and then about 16 oz. of warm water to dissolve the powder. Then the nasal adaptor is put into one nostril and the machine will gently propel half the liquid through one's nasal canal, and it will drain out the other side.

One then puts the adaptor in the other nostril and repeats the procedure on that side. This procedure is done while leaning over a sink. I then normally put more water into the tank and use the WaterPik on my teeth as it was originally intended, and I've helped my gum and dental health as well. My dental hygienist has made several comments about how much better my gums and teeth are when I go in for cleanings. The whole effort only takes about 5 minutes or so, including wiping everything dry. I normally do the irrigation once a day about an hour before bed, but if I happen to wake up with more than the usual congestion in the morning, I'll do it then as well.

The Easiest Way to Start

In the past couple of years Dr. Grossan has come up with his own machine for nasal irrigation. It is called the Hydro Pulse(R) Nasal Irrigation System. For about $89 plus shipping one receives the Hydro Pulse Nasal/Sinus Irrigator(R), 2 Original Sinus Irrigator Tips (R), 2 Original Throat Irrigator Tips(R), Breathe-ease(R) XL Nasal Moisturizer (this is the saline solution), and excerpts from,"The Sinus Cure" by Dr. Grossan.

This is the easiest way to start, as you have everything needed. If the system works well and you want to continue to do nasal irrigation on a daily basis, I would suggest purchase of a pack of one dozen saline solution boxes, as the price is lower per box and there is only one shipping charge to pay. Of course one could still purchase a WaterPik at a retail store and buy the Dr. Grossan's adaptor and saline solution to work with it. For information about how to purchase these items, and also how to download a free ebook written by Dr. Grossan, follow the links at the end of this article..

Other Medications

For many people the nasal irrigation system will be enough to control your sinus problems. Those of us with particularly significant sinusitis may need to supplement this with medications, and I use Flonase before going to bed each night as well. If I feel like I'm on the verge of a sinus infection I might take some Zyrtec (an antihistimine) or if an infection seems imminent, I have my silver bullet, which is Prednisone. I don't use much of the latter, however, as there can be side affects with this steroid. My doctor usually prescribes 10 pills of 20 mg each, and these last for about a year. I never take a whole pill and usually take 5 mg or 10 mg maximum at a time for a day or two.

I'm told this is a reasonable amount and nothing to worry about. Speaking of bad side effects, prior to discovering Dr. Grossan's system, sometimes desperate for relief, I used an over-the-counter spray called afrin. The warnings on the label say to use this product for only 4 days or less. This medication can damage the cilia in one's sinuses and cause permanent damage if used too much. As frequent users know, there is also an effect called rebound congestion, so after using it you might end up just as congested as when you started. Thus, people are tempted to continue using it, and it is said to become addictive. Dr. Grossan simply recommends that you throw your afrin into the garbage and stay away from it. I have not used it for years now and am glad to be rid of it.

I haven't eliminated sinus infections entirely, and I might come down with perhaps one per year. I'm more susceptible when very tired, or after long flights, as we often go back and forth to Europe for our tour business. When flying anywhere I make sure to take some kind of decongestant, normally the Flonase. I can enjoy wine, cheese, chocolate, and I really don't need to avoid any particular foods. Dr. Grossan's system has worked for me, and I certainly don't miss the deep, painful sinus infection headaches that used to be all too familiar. Dr. Grossan has lots of other advice in his book as well, and I definitely recommend that anyone with sinusitis read it.

Best of luck to all sinusitis sufferers. I hope this information will help improve your lives as much as it has helped me. Please don't hesitate to forward this article to friends and family who suffer from sinusitis.

Walt Ballenberger is the founder of Beaux Voyages, which offers tours in France.For information about treatments for sinusitis and post nasal drip, visit Post Nasal Drip

The Misery of Pfizer Could Be The Joy Of Texas - Generic Drugs Are On The Rise

Pfizer can't be happy. Its patent on the best-selling drug in the world, Lipitor, expires in 2011, which doesn't give the pharmaceutical giant much time to figure out how to compensate for the billions of dollars in sales that will be lost when it happens, courtesy of generic companies reproducing the medicine's active ingredients. The United States alone buys $5 billion worth of the brand-name drug every year.

It's hard to believe that the world's greatest selling pharmaceutical medicine is a treatment for cholesterol, rather than for some horrible, chronic illness. . .well, that is until one considers it purely from a business perspective. Heart disease is still the number one killer of Americans, and one-third of all deaths in this country in 2004 were attributed to it. That means big bucks for companies that can market a treatment for this exploding, life-threatening problem.

Consumers can save up to fifty percent on prescription drugs, according to the Food and Drug Administration, if they just buy generic. Generic drug companies, health insurance providers, and patients alike are practically salivating in anticipation; Lipitor's expiring patent means that not only can other pharmaceutical companies reproduce the coveted, and much guarded, active ingredients, but also that dramatic price slashes will happen for consumers. Texas, with the majority of its population now obese -- a risk factor for heart disease -- and twenty-five percent of its population going without any health insurance, particularly stands to benefit from more cost-effective medication.

But Pfizer shouldn't feel so bad; Lipitor is not the only one. In fact, experts are predicting a golden era for generic drugs as patents on several high-dollar medications come due over the next few years -- $60 billion a year worth -- including Ambien, Norvasc, Zyrtec and Fosamax. Johnson & Johnson announced last week that it will eliminate close to 5,000 jobs in preparation for the generic reproductions of Risperdal, a drug for schizophrenia, Topamax, a seizure medication, and other medicines used for migraines. In 2009, Prevacid's formula, as well, relinquishes its secrets, a heartburn and ulcer drug producing $3.5 billion in annual sales.

While advances in treatments for cancer and other potentially fatal illnesses seem promising, few new medications with mass-market appeal are waiting to replace the old. While this is bad news, indeed, for pharmaceutical giants, it seems to be great news for the rest of the population.

Such patents expiring, without comparable replacements waiting, means the drug price inflation rate will remain under ten percent, despite the aging population's ever-increasing need for medication. This figure has almost always been in the double digits in recent years, according to Steven B. Miller, chief medical officer for ExpressScripts, which manages drug benefit plans. In 2002, in fact, it was eighteen and a half percent. "(The inflation rate) is much better than it was in the '90s, before these drugs starting going generic," said Miller.

Ronny Gal, analyst for Sanford C. Bernstein, which follows generic companies' activities, predicts a ten to thirteen percent growth in the generic drug industry by 2010. "(The change) is good for everybody but the branded pharmaceutical companies."

The high sticker price of many brand-name pharmaceutical drugs is, to a large extent, due to their research and development processes; industry leaders must invest billions of dollars and spend years of time to create a viable medication. They, then, make up for such significant initial costs by setting a high sale price, thereby ensuring billions in profits. Generic companies, on the other hand, do not invest such time and resources on development, which is one of the many reasons they can sell their versions anywhere from thirty to eighty percent cheaper, though they meet the same quality standards and contain the same active ingredients.

". . .(The lack of new drug formulas is) basically a failure of innovation," said Richard T. Evans, a consultant with Avos Life Sciences, a research and consulting firm for the drug industry.

Part of that industry, however, protests such claims. Caroline Loew, senior vice-president for scientific and regulatory affairs for the Pharmaceutical Research and Manufacturers of America, a trade group for brand-name companies, defends the ups and downs of the process. "I don't think we would support the contention there's a lull." Finding treatments for chronic and complicated diseases, like Alzhiemer's, Parkinson's, and cancer, takes more time and effort than for other conditions. The production of pharmaceutical drugs is "very much an emerging science," she said, and "the biological mechanisms are very poorly understood."

The high price of brand-name pharmaceutical medications and the exploding number of those going without health insurance have combined to create a growing demand for less expensive, imported drugs. Finding the cost of their medications too much to bear, many Americans are turning to Canada and Mexico to meet their pharmaceutical needs, despite warnings against possible safety issues. Though statistics on just how many are getting their medications from foreign sources are difficult to document, border states are especially susceptible to such temptations. A trip across international lines, after all, is under a day's drive away for most Texans.

The additional criticism that drugs cost thirty to fifty percent more in the U.S. than in Europe, due to the for-profit structure of the domestic pharmaceutical industry, only adds fuel to the fire on the debate over universal health care. With healthcare systems in cities like Dallas, Houston, and Austin nearly crushed by the flood of uninsured coming in from other parts of the state to receive care, it's easy to see where the argument for universal coverage may have some validity.

Research and proper investing seem the most viable solution to the current problem of high-cost prescription drugs in the U.S. Investing in a health insurance plan appropriate to one's needs and researching the availability of generic drugs can dramatically reduce one's healthcare costs. In fact, sixty percent of prescriptions written in this country are for generic medications, and that number is expected to rise. Patients also have the right to ask for a generic version, if available, to cut costs. As usual, much of a patient's outcome depends on his or her willingness to be assertive and research those issues dramatically affecting personal health. To keep its high profits going, Pfizer is just going to have to come up with some new innovation to amaze us, and to save us, from the overwhelming tide of disease.

Being aware of issues affecting the cost of healthcare is an important aspect of minding your health. How you take care of yourself will certainly affect you as you age, and eventually your wallet, as well. If you're a young individual who tries to keep informed and maintain a healthy condition and lifestyle, you should take a look at the revolutionary, comprehensive and highly-affordable individual health insurance solutions created by Precedent specifically for you. Visit our website, www.precedent.com, for more information. We offer a unique and innovative suite of individual health insurance solutions, including highly-competitive HSA-qualified plans, and an unparalleled "real time" application and acceptance experience.

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