FDA Bans Drugs Containing Ephedra Due to Health Risks

by : Alan Haburchak

Ephedra is a naturally occurring substance derived from the Asian supplement Ma Huang and is also known as Ephedrine, Pseudoephedrine, and Epitonin. Its principal active ingredient is Ephedrine, a drug that is regulated by the Food and Drug Administration (FDA) and found in over-the-counter asthma medications.

While products containing natural Ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years Ephedra has been extensively promoted as a stimulant that aids in weight loss, enhanced athletic performance and an increase in energy levels. Ephedra is now a household name and is primarily found in various over the counter diet pills.

Originally, the FDA could not regulate the production and distribution of Ephedra because it is a dietary supplement protected under the Dietary Supplement Health and Education Act of 1994 (DSHE). According to the FDA, under this Act, the manufacturer of the dietary supplement is responsible for ensuring that it is safe before it is marketed to the public.

The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. As such, most manufacturers are not required to register their products with the FDA, nor must they get FDA approval, before producing or selling dietary supplements. The burden of proof lies on the shoulders of the manufacturers, and they are required to make sure that product label information is truthful and not misleading.

Despite the limitations the DSHE Act imposed upon the FDA to act as an agent of change, the FDA issued numerous warnings beginning in the early 1990's detailing the health risks to consumers of products containing Ephedra.

Since the FDA was not able to regulate ephedra effectively until after millions of Americans had already consumed the stimulant, many consumers are unaware that suppliers of products containing the drug were able to make health and weight loss claims about these substances without a scientific basis. These suppliers also neglected to disclose the harmful and potentially deadly side effects of the products.

In 1994, the FDA began receiving many reports regarding the side effects of products containing Ephedra. While Ephedra-containing products account for less than one percent of all dietary supplement sales, the drug accounts for an alarming 64 percent of adverse events associated with dietary supplements.

Between 1994 - 2002, the FDA received more than 800 reports of adverse effects from Ephedra and Ephedrine alkaloids. These included but are not limited to:

* High blood pressure.

* Heart rate irregularities.

* Insomnia, nervousness.

* Tremors.

* Seizures.

* Heart attacks.

* Strokes.

* Brain hemorrhages.

* Death.

Ephedra's effects are similar to that of adrenaline and it affects the central nervous system. Ephedra acts as a stimulant and it can cause rapid or irregular heartbeats, chest pain, psychosis and tremors. Ephedra dilates the bronchial muscles, contracts nasal mucosa, raises blood pressure, and is a cardiac stimulant. Complications from these adverse effects can result in strokes or heart irregularities that can cause cardiac arrest or death.

New medical research has suggested that ephedra can also cause primary pulmonary hypertension, a disabling and fatal condition of the lung. Reports of these adverse side effects have increased in recent years and include the deaths of a few high profile athletes.
Ephedra is a dangerous and potentially life threatening drug. As such it has become critical to monitor its production, distribution and use.

Perhaps this is why, in 2003 the states of California, Illinois and New York individually took action and banned the use of ephedra products. This in turn encouraged the Federal Government to move more quickly towards a blanket ban on the stimulant.
In December 2003, the Department of Health and Human Services (DHHS) and the FDA announced the intention to ban Ephedra.

The DHHS stated that Ephedra can be linked to numerous health dangers and the FDA then urged consumers to immediately stop consuming products containing the drug. The FDA also strongly encouraged manufacturers to recall products still on the shelves.

Effective April 12, 2004, the FDA banned the sale of all Ephedrine over the counter dietary supplements, having concluded,"the totality of the available data showed little evidence of Ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke."

It is now against the law to purchase or sell all dietary products containing Ephedra. The FDA notified 62 companies that market products containing Ephedra of the ban. Prior to the FDA ban one of the most popular supplements containing Ephedra was Metabolife356, which was manufactured by Metabolife International, Inc.