Ephedra-containing products

Since 1994, the Eood and Drug Administration (EDA) and Centers for Disease Control collected reports of over 100 deaths and 500 reports of adverse events associated with ephedrine-containing dietary supplements over a 2 year period. The NCAA banned the use of ephedra-containing products since 1997, and the Olympics banned the use of ephedra for over a decade. 

Use of ephedra-containing products is likely unsafe during pregnancy because of reports of psychoses and cardiovascular effects (79,104,145). 

Ma huang (ephedra) is commonly found in herbal weight loss products that are often referred to herbal fen-phen. Some weight loss clinics and herbal outlets promote Herbal fen-phen as an alternative to fenfluramine, the prescription drug that has been withdrawn from the market due to toxicity. Herbal fen-phen products sometimes contain St John s wort and are sold as herbal prozac . Ephedra-containing products are also marketed as decongestants, bronchodilators and stimulants. Other promoted uses include bodybuilding and enhancement... 

Analysis of active components of ephedra-containing products... 

Even before the FDA s official ban, many supplement companies volunteered to pull their own ephedra-based products from shelves. They also scrambled to come up with a similar ingredient after news of Bechler s death. Newer, ephedra-free supplements contain HCA, bitter orange, or other so-called thermogenic substances, often combined with each other. 

As with other sympathomimetic agents, theoretical drug interactions with ephedra alkaloids are possible. Despite this potential, only a handful of adverse drug interactions have been reported. This is especially pertinent when considering the extensive use of both ephedra-containing supplements and ephedrine- or pseudoephedrine-containing OTC products. The most notable interaction exists between nonselective monoamine oxidase inhibitors and ephedra- or ephedrine-containing products. 

With the ban of ephedra-containing dietary supplements and severe restrictions in access to ephedrine-containing OTC products, the landscape of clinical use associated with agents of this nature has been dramatically changed forever. Interest in further clinical study will likely be severely limited. 

The world war made all these sources of supply difficult of access and stimulated interest in the possibilities of local production. Examination of a number of American species of ephedra had already shown them to be devoid of alkaloids, except for the S. American species E. andina, in which Chavezt found ephedrine, and in the United States attention has been given to the experimental cultivation of imported species, notably E. sinica and E. gerardiana a Moroccan type, E. alenda, was found to contain only ). In Australia experimental cultivation of the Indian species E. gerardiana, E. intermedia and E. nebrodensis has been tried and preliminary yields of 1-35, 1-OS and 0-98 per cent, of total alkaloids respectively have been recorded. In Russia, E. equisetina and E. intermedia are available and are considered to be worth exploitation. In Italy various local species have been found to contain mainly i -ephedrine and that in small amount, but better results are recorded for two species already referred to and which are available in Sardinia, viz. E. vulgaris Rich and E. nebrodensis. ... 

Products containing ephedra were used extensively by the American public for weight loss and to enhance athletic performance. Ephedra, a stimulant similar to amphetamine, increases blood pressure and heart rate after only one dose, significantly increasing a person s risk of heart attack, stroke, and death. Because ephedra is a dietary supplement, the FDA did not review its safety or efficacy before it became available to the American public. According to law, the FDA could only prohibit the sale of the dietary supplement if it was proven to present a significant or unreasonable risk of injury. 

The agency is permitted to restrict substances that pose a "significant and rmreasonable risk" rmder the conditions of use on the label or as commonly consumed. The FDA has the burden of proof and cannot act rmtil substantial harm occurs to consumers, but manufacturers are not required to report adverse events. Even when harm is obvious, instituting a ban can take years. For example, even though thousands of consumers appear to have been affected by products that contain ephedra, it took the FDA more than 5 years to go through the procedures needed to ban its use. 

Many CAMs are derived from natural sources such as herbs and other plants. Therefore, some consumers assume that a natural product is inherently safer than a synthetic or manufactured chemical.57 These individuals may likewise believe that they can take an unlimited amount of a CAM that is, they may exceed dose limits with the idea that the product can do no harm. These misconceptions can lead to tragic consequences, as was the case with ephedra. Ephedra, derived from an evergreen shrub, also contains epinephrine (adrenaline). As discussed in Chapter 20, epinephrine is a powerful agonist (stimulant) of alpha and beta receptors on various tissues throughout the body. People took... 

FDA proposes new rules regarding ephedra, which would have considered some products containing ephedra as adulterated supplements, making them subject to FDA regulation. The FDA based its adul-... 

Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra. 

Today, supplements containing ephedra are at the center of a controversy, with opponents claiming that they are dangerous and should be banned. Supplement makers and the herbal products industry, however, maintain that ephedra is safe and reports of adverse effects are overblown, exaggerated, and inaccurate. The Food and Drug Administration (FDA) has received hundreds of reports of adverse effects of ephedra, including strokes,... 

Since 1997, a number of groups have lined up on each side of the ephedra battle. A non-profit group called Halt Ephedrine Abuse Today has spoken out about the dangers of ephedra. On the other side of the battle is the Ephedra Education Council, a group backed and supported by the herbal products industry and supplement manufacturers. Many of the companies that sell products containing ephedra do not want any further restrictions on the products. 

The United States is not the only country concerned about the safety of ephedra. Health Canada, the Canadian health regulatory agency, requested a voluntary recall of products containing both natural and chemical ephedra in 2002, because it received 60 reports of adverse events related to ephedra use. 

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