Fwd: Asthma Drug May be Associated With Life-Threatening Side Effects (Dr Mercola)

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Asthma Drug May be Associated With Life-Threatening Side Effects

 

Dr. Mercola : www.mercola.com

 

March 2003

 

A study designed to further evaluate the safety of asthma drug Serevent was

called off after an interim analysis showed more life-threatening asthma

episodes and asthma-related deaths in patients taking the drug than in those

taking a placebo.

 

The study was begun in 1996 after the Food and Drug Administration (FDA)

received reports of several asthma deaths associated with use of the drug.

Preliminary data showed a small, statistically insignificant number of adverse

events in relation to use of the drug, however, among African Americans taking

Serevent the number or adverse events, including deaths, was statistically

significant.

 

Further, according to national treatment guidelines, asthma sufferers should

take Serevent along with an inhaled corticosteroid daily. Preliminary study data

showed that patients who were not taking inhaled corticosteroids at the study’s

start seemed to have greater risk for serious outcomes than those who were

taking inhaled corticosteroids.

 

Though the study’s data was inconclusive, the adverse events were enough to

cause researchers to question why the events were happening, and the study

wasn’t designed to determine that. About 26,000 people had participated in the

study so far, though the study was intended to enroll 60,000 patients.

 

The FDA plans to meet with Serevent’s manufactuer, GlaxoSmithKline (GSK), to

obtain more detailed data and determine what further steps should be taken.

Among the FDA’s top priorities is to evaluate whether certain patients may be at

an increased risk for serious adverse events due to Serevent use. The FDA

approved Serevent in 1994 to treat asthma and later for use in the treatment of

chronic obstructive pulmonary disease.

 

However, the FDA stressed that patients should not stop taking Serevent without

discussing it with their doctors. Based on the available evidence, they say that

the benefits of Serevent outweigh the risks of adverse events.

 

About 20 million people suffer from asthma in the United States, and an

estimated 1.3 million take Serevent. The asthma drug is one of GSK’s major

sellers with worldwide sales of $929 million--$549 million in the United

States--in 2002. Analysts did not expect the cancelled study to greatly

influence the company’s economic standing.

 

FDA January 23, 2003

DR. MERCOLA'S COMMENT:

Serevent is a popular asthma inhaler that has worldwide sales close to $1

billion--it is a classic example of the Band-Aid approach that traditional

medicine has to chronic illness. Find an expensive drug solution that drug

companies can reap huge profits from and ignore the underlying foundational

causes as no one makes much money on finding solutions for the cause.

 

This is because once you have solved the problem, you can’t continue to sell

them the Band-Aid. The problem with this shortsighted and self-serving approach

is that it ignores the central issue that humans will perpetually have health

problems, as that is the nature of being alive.

 

It is just a matter of degree. Rather than having to struggle with

life-threatening disabling challenges we could focus on fine-tuning the

challenges of improving our emotional base and relationships so we can more

fully express love in our lives and improve the quality of society in general.

 

With respect to asthma, simple changes can produce very profound improvements in

your ability to breathe. Following the nutrition plan is one of the first

steps--avoiding sugar, fruit juices, most grains and pasteurized dairy products

is nearly always helpful. Replacing commercial milk with raw milk from grass-fed

cows is also usually well tolerated and highly health promoting.

 

Making certain that enough long-chain omega-3 fats (DHA and EPA) from fish oils

are included in your diet is also helpful. I find Carlson fish oil and cod liver

oil to be one of the most superior brands available as it conforms to the

strictest guidelines for purity and freshness. It is available in most health

food stores, and Carlson fish oil and cod liver oil are also available in our

online store.

 

It important to realize that spring is around the corner and for many of you

that will mean that you will be getting regular sun exposure. If that is true

for you it is important to switch from cod liver oil to fish oil at this time of

year to prevent vitamin D toxicity.

 

The best way to know whether your vitamin D levels are within safe limits is to

check your blood level of vitamin D, but I know it's likely that many of you

will not be doing that. So be on the safe side and switch over to fish oil now

unless you know for sure that your vitamin D levels still require some further

boosting.

 

The best way to know this for certain would be to check you blood level of

vitamin D, but I know many of you will not be doing that. So be on the safe side

and switch over to fish oil now unless you know for sure that your vitamin D

levels still require some further boosting.

 

For more severe and resistant cases of asthma, allergy skin testing can be

appropriate. Traditional allergy treatments are one of medicine’s safer and

better approaches, however it has great room for improvement. My experience with

conventional allergy testing, whether done through the blood (RAST) or skin is

that only 20 percent to 30 percent of patients do exceptionally well with it. It

is also highly inconvenient, as patients need to go to the doctor’s office every

week for months or years. It clearly does not work for the majority of patients.

 

For the last 10 years, I have been using a much improved version of this

testing, which is taught by the American Academy of Environmental Medicine,

called Provocation Neutralization (PN). The success rate for this approach is in

the 80 percent to 90 percent range and patients can receive their treatment at

home.

 

Both systems are time consuming and expensive though. A course of PN treatment

and testing can run about $1,000 to $2,000. However, this is less than many

patients are already spending on one year’s worth of allergy medicines, and it

is a long-term solution that will, in most cases, provide a permanent treatment.

There are also virtually no side effects with the treatment, unlike with

conventional drugs.

 

It is important to remember that the allergy desensitization program is in

addition to, not a replacement for, a comprehensive nutritional approach.

 

Related Articles:

Hygiene Hypothesis of Asthma

Omega Three and Childhood Asthma

Writing (Journaling) About Stress Helps Asthma, Arthritis

 

 

 

 

 

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