I Advice - Health and Fitness

It’s been called the world’s oldest medicine, the miracle fat burner, and is known in some parts of the U.S. as “Mormon tea.” Ephedra (also called Ma-huang or epitonin) has been used for its healing powers for more

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

than 5000 years by the Chinese, who discovered the plant’s healing properties. So why was it banned by the U.S. Food and Drug Administration in 2004, and more importantly, why was the ban recently lifted?

What is E

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

phedra?

Ephedra grows all over the world, and in the Western United States, this flowering shrub can be found in deserts and sagebrush areas. The plant can be ground into powder for capsules, or dried and used in t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ea. Ephedrine is the “active” ingredient in ephedra, responsible for its healing properties. Ephedrine is a nerve stimulant similar to adrenaline, but not as strong as amphetamine.

What Does It Do?

Dieters have lo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

ng known the powerful effects of ephedra in promoting weight loss. Basically, ephedrine creates a thermogenic response, speeding up metabolism and expediting the body’s fat burning rate while preserving muscle. Ephe

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

dra has proved to be particularly effective for people with a slow metabolism, who have previously had trouble losing weight.

Additionally, ephedrine can be used to treat bronchial asthma and cough by relaxing the

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

air passages in the lungs. For this same reason, the plant is helpful in treating the effects allergies and hay fever. Ephedra can assist in fighting a minor cold by causing perspiration and urination (to relieve sw

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

lling and fluid retention). Alternative uses for ephedra include treating muscle and joint conditions such as bursitis, arthritis, and rheumatism. A synthetic (man-made) replacement, called pseudoephedrine, was crea

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ted and is widely used in common over-the-counter medications such as Sudafed.

Why the Ban?

Possible side effects of ephedrine include insomnia, dry mouth, nervousness, general weakness, poor digestion, irritabili

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ty, headache, dizziness, increased blood pressure, increased heart rate, and heart palpitations. Not surprisingly, this list is markedly similar to over-the-counter medications with the active ingredient pseudoephed

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rine.

Some argue that the pharmaceutical companies have organized lobbyists to target ephedra because it was cutting into their sales for weight loss drugs and asthma drugs (bronchodilators). Others believe ephedra

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

is not dangerous, but simply got some bad press as a result of a handful of people who intentionally misused ephedra or a synthetic replication of the isolated part of ephedra (ephedrine). Ephedra activists insist

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

that human nature simply cannot be regulated and no one can control how people use (or abuse) any supplement, herb, or drug. How can you protect customers who ignore warning labels or double their doses?

The FDA in

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

flicted a ban on ephedra in late 2003 (which became effective in early 2004), declaring an “unreasonable risk.” This decision was based on public comments, literature review, adverse event reports and scientific stu

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ies. Dieters were devastated, feeling that their right to safely and appropriately use this herb had been stripped from them.

Why Was the Ban Lifted?

After the conclusion of several court cases (including some hig

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

h-profile cases), the FDA stated in its final ruling that only five deaths were attributed solely and directly to ephedra. Keep in mind, according to the American Herbal Products Association, approximately 12 to 17

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

million people consumed ephedra during 1999. Ephedra sales in 2002 were close to $1.3 billion. What you may not know is that in 1994, over 100,000 people died due to adverse reactions or overconsumption of prescript

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ion drugs.

Is Ephedra Safe to Use?

According to the FDA, ephedra is safe for human consumption when it is taken in the recommended dosages, and when all warning labels are strictly observed. Obviously, women who a

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

re pregnant or nursing, and people with certain diseases (such as high blood pressure) should NOT consume ephedra or ephedrine. It is advised that you check with your physician before taking ephedra.

Where Can You

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

Get Ephedra?

Currently, one company claims to be the only U.S. supplier of ephedra for weight loss. You can purchase ephedra online at www.BetaFuelDirect.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Start with the outside of your home. First, make sure all weeds and brush are cleared away from the home- this helps keep the fire danger low and that, in turn, helps to keep your insurance rates lower.

Dr. Silva gives advice to distributors that have been treated unfaily by those few dishonest management teams.

Wonder what the first goal oriented game ever made was? Look no farther than the Maxis classic Sim City. Not familiar with it? The following review will give you a decent idea of what it as all about.

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I Advice - Ephedra Is Back - But Is It Safe?

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