Ephedra

Related Topics:
Ephedraceae :: Ephedra :: Ephedra_sinica :: Ephedra_viridis :: Ephedra_fragilis :: Ephedra_gerardiana :: Ephedra_nevadensis

Species of Ephedra have traditionally been used by indigenous people for a variety of medicinal purposes, and are a likely candidate for the Soma plant of Indo-Iranian religion. Also known as ma huang, it was used in traditional Chinese medicine up to 5,000 years ago, probably for the treatment of asthma and hay fever. In the late 1900s, it was used as a stimulant and a dieting aid. Due to the risk of adverse effects on the cardiovascular system, Western medical professionals recommend against the consumption of any ephedra.^*

Chemistry

The alkaloids ephedrine and pseudoephedrine are the active constituents of the plant. Pseudoephedrine is used in over-the-counter decongestants. Ephedrine is used to treat low blood pressure, but alternatives with reduced cardiovascular risk have replaced it for treating asthma. It is also considered a performance-enhancing drug and is prohibited in most competitive sports. Some species in the Ephedra genus have zero alkaloid content and are therefore essentially inert, however the most commonly used species, Ephedra sinica, has a total alkaloid content of 1–3% by dry weight. Ephedrine constitutes 40–90% of the alkaloid content, with the remainder consisting of pseudoephedrine and the demethylated forms of each ^*.

Effects

Ephedra is both a stimulant (similar to adrenaline) and a thermogenic. It stimulates the brain, increases heart rate, constricts blood vessels (increasing blood pressure), and expands bronchial tubes (making breathing easier). Its thermogenic properties cause an increase in metabolism, evidenced by an increase in body heat.

Side effects of ephedra may include irritability, nervousness, dizziness, trembling, headache, vomiting and hyperthermia. Chemical dependence may also develop.

Safety

Just like other stimulants such as Ritalinhttp://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682188.html, in high doses ephedra can cause heart attacks, stroke, and seizures^*. Yet, because ephedra is unregulated and because its primary use is now for weight-loss, there is additional concern about safety due to dieters taking more than the recommended amount, hoping to lose weight faster.

The FDA maintains that "^* is dangerous at any dose"http://www.sltrib.com/portlet/article/html/fragments/print_article.jsp?article=3800052. But there are many people including experienced users of ephedrahttp://health.groups.yahoo.com/group/ephedraforum who don't agree with the FDA. One popular website with a focus on ephedra puts questions the FDA's recommendation, asking, "If ephedra is as dangerous as the FDA claims it is, given that the Chinese have been using it for 5,000 years, shouldn't they have experienced enough adverse events to be wary of it? If the FDA is so forceful in its opinion that any amount of natural ephedra is harmful, why does it allow you to buy Big Pharma's synthetic versions of ephedra, 240mg pseudoephedrinehttp://www.sudafed.com/products/24hour.html and 25mg ephedrinehttp://www.drugstore.com/products/prod.asp?pid=152878&catid=9327&trx=29384&tab=0#0 without a prescription? Unless natural ephedra is more dangerous than its synthetic form, it's disingenuous to prohibit the sale of natural ephedra if the synthetic form can be sold without a prescription!"http://www.ephedra.com/ephedra-opinion.htm

Regulatory history in the United States

Beginning in the 1990s, concerns about the safety of Ephedra and Ephedra-based products began to be publicly raised in the United States. Concentrated mixtures were found in weight control products marketed as "dietary supplements". Sympathomimetic amines such as ephedrine raise heart rate and blood pressure and can be particularly hazardous to those with pre-existing cardiac problems. After receiving over 800 reports of "adverse events", the country's federal Food and Drug Administration (FDA) proposed regulations in 1997 for a warning label, and a limited dose of 8mg (no more than 24mg per day).http://injury.findlaw.com/ephedra/ephedra-overview(1).html

After various petitions for and against the regulations, (including complaints about the accuracy of dosage and lack of quality control in the dietary supplement industry http://www.webmd.com/content/article/23/1728_56810.htm) the FDA hired the RAND Corporation to do a study in 2002, http://injury.findlaw.com/ephedra/ephedra-overview(1).html and eventually linked 155 deaths to Ephedra, most of them caused by cardiac problems and strokes.

In May 2003, the health food store General Nutrition Center announced that they would stop carrying ephedra-containing products as of June 2003. ^*

The FDA must approve all drugs before they may be sold in the United States. It considers the risks and benefits of medications for specific medical conditions, may require a doctor's prescription, make labeling requirements, or ban the drug entirely. The burden of proof for safety is on the manufacturer. The Dietary Supplement Health and Education Act of 1994 creates a class of substances known as dietary supplements, which are not subject to pre-approval, and for which the burden of proof is on the government if it wishes to restrict availability. As a traditional herb, Ephedra qualifies as a dietary supplement.

On December 30 2003, the FDA announced a ban (effective 12 April, 2004) on the uncontrolled sale of dietary supplements containing Ephedra, citing "an unreasonable risk of illness or injury" from the use of the drug. The active ingredients ephedrine and pseudoephedrine remained available as an ingredient in some over the counter (OTC) medications that are clearly labeled in accordance with FDA regulations. Chemicals created in a laboratory do not qualify as dietary supplements, even if they are the same as those found in natural products.

Many advocates maintained that Ephedra was safe in low doses typical of traditional herbal preparations, and that the adverse cardiovascular effects were associated with higher doses.

The Nutraceutical Corporation of Park City, Utah, which had been selling a relatively low dose (10mg, compared to 40mg-100mg doses also on the market) sued the FDA. On 14 April 2005, Utah federal district judge Tena Campbell ruled in favor of the company.^* The ruling stated that because of the 1994 law and Ephedra's status as a dietary supplement, the FDA did not have the statutory authority to require the manufacture to prove that the product offered a benefit, and that it had failed to meet its burden of proof that the 10mg dose posed a sufficient risk. Nutraceutical said that it did not plan to re-introduce Ephedra, and that it had brought the suit merely to protect its other product lines from overzealous regulation by the FDA. The FDA said that it considered further research into the dose-dependent safety of Ephedra to be unethical, given the lack of benefit (other than for short-term weight loss http://www.nutraingredients-usa.com/news/printNewsBis.asp?id=60687) and potential risk."Judge's Decision Lifts Ban On Sale of Ephedra in Utah." Gardiner Harris and Jay Schreiber. New York Times. April 15, 2005. ^* Critics renewed calls to reform the 1994 dietary supplement law.http://www.steroidlaw.com/?pageID=49 "Experts debating scope of decision." San Diego Union-Tribune. Penni Crabtree. April 16, 2005. ^*

The state of California banned Ephedra dietary supplements in January 2004, followed by New York and Illinois. These laws are not affected by the federal court decision. http://signonsandiego.printthis.clickability.com/pt/cpt?action=cpt&title=SignOnSanDiego.com+%3E+News+%3E+Business+--+Ephedra+ruling+puzzles+industry&expire=&urlID=13920767&fb=Y&url=http%3A%2F%2Fwww.signonsandiego.com%2Fnews%2Fbusiness%2F20050416-9999-1b16ephedra.html&partnerID=621

In professional sports

In the 1994 FIFA World Cup, the Argentine footballer Diego Armando Maradona tested positive for ephedrine in a doping control for using one dietary supplement product containing the substance. The Japanese motorcycle racer Noriyuki Haga tested positive for it in 2000, being disqualified from two races and banned from two more as a result.

The U.S. National Football League banned players from using ephedra as a dietary supplement in 2001 after the death of Minnesota Vikings offensive tackle Korey Stringer. The substance is also banned by the National Basketball Association.http://query.nytimes.com/gst/fullpage.html?res=9C04E0DF113EF936A25757C0A9639C8B63&sec=health&pagewanted=print

Baseball pitcher Steve Bechler of the Baltimore Orioles died in 2003 after taking the supplement that same year. ^* Later that year, his widow filed a $600 million wrongful death lawsuit against the manufacturer.http://injury.findlaw.com/ephedra/ephedra-overview(1).html

NFL player Todd Sauerbrun of the Denver Broncos was suspended for the first month of the 2006 season after testing positive for the banned supplement ephedra.

External links

United States FDA links to actions
FDA Rule
United States NIH Factsheet regarding weight loss and athletic performance

References

Antiobesity agents | Herbal and fungal stimulants | Amphetamines

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