Asthma Drug Linked to Serious Adverse Events 10-9-08

LONDON, Oct. 9 -- For chronic asthma, the regular use of formoterol is associated with a significant increase in non-fatal serious adverse events, according to a systematic review of the literature.

In an analysis of 22 randomized trials, regular formoterol use was linked to a 57% increase in non-fatal serious adverse events compared with placebo (OR 1.57, 95% CI 1.05 to 2.37), Christopher Cates, B.M.B.Ch., of St. George's University of London, and colleagues reported in a Cochrane Review.

For every 1,000 asthma patients treated, they said, there would be an expected 16 adverse events with formoterol compared with 10 with placebo.

The increase in non-fatal serious adverse events was greater in children (OR 2.92, 95% CI 1.26 to 6.74) than in adults (OR 1.22, 95% CI 0.76 to 1.96), but the difference between the age groups was not statistically significant.

"It is possible that children are at a higher risk of suffering serious effects due to this drug, but we can't say for sure," Dr. Cates said. "We would urge that all serious adverse events are more fully reported in medical journals so that we can make a better assessment of drug safety."

The review followed a similar one released in July that found that another long-acting beta2-agonist, salmeterol (Serevent), increased the likelihood of having a non-fatal serious adverse event. (See: Salmeterol (Serevent) Increases Serious Adverse Events in Chronic Asthma)

Although long-acting beta2-agonists have been shown to be effective for relieving the symptoms of asthma and improving lung function and quality of life, safety concerns continue to be raised, the researchers said.

So they reviewed both published and non-published data from studies comparing once- or twice-daily formoterol alone with placebo or short-acting beta2-agonists such as albuterol and terbutaline.

The 22 studies included in the review were at least 12 weeks long and covered 6,693 adults and 1,339 children.

Doses of formoterol ranged from 4.5 mcg to 24 mcg twice daily in children and 6 mcg to 24 mcg twice daily in adults.

Concurrent use of inhaled corticosteroids ranged from zero to 100% in the studies.

The increased risk of non-fatal serious adverse events with formoterol became non-significant when patients taking the highest dose were excluded (OR 1.51, 95% CI 0.95 to 2.31).

Three deaths occurred in patients taking formoterol compared with none in placebo patients, although the difference did not reach statistical significance (OR 1.52, 95% CI 0.24 to 9.71).

"It was not possible to assess disease-specific mortality in view of the small number of deaths," the researchers said.

When fatal and non-fatal adverse events were combined, there was an increased risk of having an event in patients taking formoterol (OR 1.63, 95% CI 1.08 to 2.44).

In addition, there were significant increases in asthma-related serious adverse events (OR 1.90, 95% CI 1.03 to 3.48) and hospitalizations (OR 4.28, 95% CI 1.60 to 11.46) in patients taking formoterol.

There was no significant increase in fatal or non-fatal adverse events when comparing formoterol with albuterol or terbutaline.

The researchers said that long-acting beta2-agonists may increase serious adverse events through direct toxicity, because of tolerance to the drugs, by delaying the seeking of medical help, and through the reduction in the use of inhaled corticosteroids.

They added that, "although large numbers of participants have been treated with regular formoterol, the rarity of mortality and serious adverse events means that there is still considerable uncertainty in relation to the size of the effects being investigated."

Comment:

Those with severe uncontrollable asthma; There is help without chronic medication!
First of all you need to eat a grain free diet. This act alone cures an astounding 82% of Asthma, COPD and Chronic Bronchitis, so it is definitely worth doing!

As you may or may not know, the more you use a rescue inhaler the less it works! A rescue inhaler should only be used as a last resort. When you first start to feel an asthma attack coming on you need to be pro active right then by relaxing, putting a drop of Breathe Ease Essential Oil Blend on your chest and wrist, drinking hot coffee, taking lobelia capsules, proper breathing techniques and or mixing any of these methods to get relief so that you can you less or no rescue inhaler! Also get a AeroChamber or other spacer to make better use and technique of your inhaler! Get a Peak Flow Meter, find your appropriate range and work at getting into that range. Believe it or not, you need to exercise the lungs! Learning proper breathing, playing an instrument that requires blowing, or a lung exerciser ( respiratory muscle trainer), walking, singing daily, or swimming are all great ways to build up your lungs and get rid of asthma and at least stay within your peak flow and reduce medication.

Being naturally proactive about your asthma is the best way to reduce medication and improve quality of life. Take molecularly distilled fish oil 2 times a day (2-4 Nature's Way Fisoil or 4-6 1000mg capsules of regular fish oil). Fish oil is an amazing anti-inflammatory and works like a steroid. Use Bella Mira Breathe Ease Oil Blend as Part of your asthma regimen. It stops an asthma attack within a minute for me!

Reducing all dirty and foreign particles your children's air not only raises IQ, but reduces asthma and allergies. The greatest gift you can give your children as well as yourself is to quit smoking. If you choose not to, at least never allow smoking in your house or car even when your children aren't present. The over 3000 chemical particles found in cigarette smoke cling to everything and can be stirred back up at anytime.

Use allergen barrier covers for all mattresses and pillows. They are not plastic like they used to be and are not noticeable at all under sheets. If you have to have carpets in your Child's room vacuum weekly and use Fabreeze Allergen Reducer (Do Not use Regular Fabreeze use only the one marked Alleregen Reducer, Do not use any Fabreeze if you have Multiple Chemical Sensitivity) or a dust mite spray on all fabric or furry things. Always run an ionizing HEPA filter. The Holmes brand room size for under $25 works just fine!

When it comes to carpet care there is a brand of vacuum that uses water to run the air through so 100% of all airborne pollutants are captured. It's called HYLA and is the best vacuum around. For more information on it email me. In your current vacuum make sure you use HEPA Filters if your vacuum has them. Or buy the strongest filtration you can get. If you have a bin type (bagless) vacuum, never empty inside the home; all the dust you just vacuumed up will go everywhere.

If you have a furnace don't use those cheap Blue filters. Make sure your filter has a MERV rating of 7+ or it is useless. A MERV 7 or higher filter will remove mold, dander and many other dangerous pollutants.

Strive to use no chemical cleaners. These release harmful volatile organic compounds into the air. Read the Article Easy Substitutions for Healthier Living for hints on switching to healthy cleaners.

If you own pets bathe them at least once a month. Feed them correctly and they will produce very few allergens.

Following these simple tips will drastically reduce dust and millions of other nasty particles; which will keep you and your children healthier and drastically reduce asthma. .