Ephedra adverse effects

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,... 

The FDA has been receiving reports of adverse effects related to ephedra use since the early 1990s. Many of the initial concerns were linked to one ephedra product—Formula One. However, when state and federal agencies investigated the product, they could not prove that it contained ephedra, and after the manufacturer of Formula One reformulated the product, reports of adverse events linked with the product ceased. But there have been many reports of adverse events associated with ephedra since 1994. The severity of those events spurred the FDA to action, which sought an independent review in an attempt to determine if ephedra had been the cause. Another purpose of the independent review was to determine the risks of consuming ephedra. 

Proposed indications Popular products containing ephedra extracts Label ingredient indicating ephedra compounds Adverse effects... 

Many cases of serious adverse effects and even fatalities have been reported that were linked with ephedra or ephedrine administration over the last 10 years. Haller and Benowitz published a review of 140 reports of adverse events related to the use of ephedra alkaloids that were submitted to the FDA between June 1997 and March 1999. Using standardized rating system for assessing causation, 31% of the cases were considered to be definitely or probably related to the use of ephedra alkaloid-containing supplements, and another 31% were deemed to be possibly related. Among these adverse events, 47% involved in cardiovascular symptoms and 18% involved the CNS. Hypertension was the most frequent adverse effect, followed by palpitations, tachycardia, or both stroke and seizures. Ten events led to death and 13 cases produced permanent disability. 

The overall conclusions drawn from all these studies are that the adverse effects of ephedra may be amplified, sometimes culminating in death, due to the following reasons ... 

Herbalists also believe that combining herbs improves efficacy and reduces adverse effects. When compounded by knowledgeable practitioners, some of the remedies do make sense. The combination of Devil s claw, white willow, and tumeric, all agents with antiinflammatory effects, is rational, and quite probably effective. But combining St. John s Wort, which contains a selective serotonin reuptake inhibitor, with Ephedra, which causes increased catecholamine release, is both dangerous and ill advised. 

Because of their adverse effects, the Food and Drug Administration (FDA) has taken action to remove two over-the-counter products that have amphetamine-hke action ephedrine, an agent with actions similar to those of epinephrine and the main active ingredient in the herb ephedra, used for weight loss and in energy-enhancement cold medicines and weight loss... 

The herbal dietary supplement ephedra, commonly known as mahuang, is used as an energy boost and for losing weight. Ephedrine and pseudoephedrine are components of ephedra that have a stimulant and bronchodilation effect. However, ephedra has an adverse effect of palpitations—which can result in stroke. 

Many reports of adverse effects due to the use of bitter orange, as a replacement for ephedra, in weight-loss dietary supplements have reeently emerged. Some of the reported effects include ischemic colitis, angina, elevated blood pressure, and other cardiovascular effects. " Synephrine and/or octopamine are speculated to play a role in the advent of such effects. ... 

There are a number of physiological effects related to ephedra consumption, and it is these side effects and reports of adverse events that are causing both the FDA and several state regulatory bodies to consider regulating it. 

According to the researchers, nearly half of the adverse events definitely, probably, or possibly caused by ephedra were cardiovascular side effects. The most common cardiovascular side effect was hypertension, or high blood pressure. Other reported cardiovascular events were palpitations, tachycardia (an abnormally fast heartbeat), stroke, and seizures. The researchers stated that 10 of the adverse events definitely, probably, or possibly caused by ephedra resulted in death, and 13 of the events caused permanent disability. In one-fifth of the cases, there was not enough evidence or information about the incident, and the remaining complications were not related to ephedra. 

Manufacturers of dietary supplements take a different stance when it comes to adverse events reporting. They claim that adverse events are anecdotal records and do not prove that ephedra caused the side effect or... 

Ephedra supplements typically contain caffeine, and users may consume caffeine in carbonated beverages, coffee, or tea. Researchers suspect that caffeine may enhance ephedra s stimulant effects on cardiovascular and/or central nervous system responses. This may account for the types of adverse events that have been reported by ephedra users. 

Although the FDA, some medical authorities, and some states recognize that ephedra and its relative, phenylpropanolamine (PPA), may cause adverse health events or serious side effects, ephedra is not considered an addictive, habit-forming drug. Drug treatment and rehabilitation programs, therefore, do not address ephedra or PPA use. 

Scientists have conducted several studies and the totality of the available data showed little evidence of the effectiveness of ephedra 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. On Eebruary 6, 2004, the EDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because such supplements present an unreasonable risk of illness or injury (Table 2). 

The ephedra alkaloids are all sympathomimetic amines, which means that a host of drug interactions are theoretically possible. In fact, only a handful of adverse drug interactions have been reported in the peer-reviewed literature. The most important of these involve the monoamine oxidase inhibitors (MAOI). Irreversible, nonselective MAOIs have been reported to adversely interact with indirectly acting sympathomimetic amines present in many cough and cold medicine. In controlled trials with individuals taking moclobemide, ephedrine s effects on pulse and blood pressure were potentiated, but only at higher doses than those currently provided in health supplements (137). Ephe-drine-MAOI interaction may, on occasion, be severe enough to mimic pheo-... 

Herbal substitutes for dru [s of abuse A variety of herbal mixtures are offered for sale in magazines, on the internet and in so-called smart , eco or head shops. Many are marketed as herbal Ecstasy and the plants included in the formulations include Yohimbe bark, Kava-Kava (Piper methysticum),Y-3 e.emi, Hops, Jaborandi and Alisma. One product contains Kava-Kava, Guarana, Uva Ursi and Cascara bark. Many of the products sold as herbal Ecstasy contain either Ephedra sinica (Ma huang) or the Indian plant Sida cordifolia which both contain the alkaloid ephedrine (see R03c, Chapter VI). Other alkaloids may also occur, such as pseudoephedrine, norephedrine and norpseudoephedrine. The side-effects of ephedrine include tachycardia, anxiety, insomnia and arrythmias and a hypotensive crisis may develop if monamine oxidase inhibitors are also taken. Many adverse reactions and more than 20 deaths have been attributed to ephedrine and Ephedra consumption. Research conducted in the US shows that the daily intake of some Ephedra products would give ephedrine levels well above the recommended therapeutic doses. 

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