Yourlawyer.com (Bitter Orange News) http://www.yourlawyer.com/topics/overview/bitter_orange Sat, 21 Nov 2009 01:20:23 -0800 pixel-app en Experts Warn that Bitter Orange May Be as Dangerous as Ephedra http://www.yourlawyer.com/articles/read/10810 Wed, 12 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10810
A new study from the University of California, San Francisco has shown, that in similar doses, bitter orange alone is not as potent as ephedra. In the 10 experimental subjects who tried it, bitter orange increased the heart rates, but not as much and not for as long as ephedra, said Dr. Christine Haller, an assistant professor of medicine who led the study.

The drug may have some dangerous effects, however. The same study reports that when bitter orange peel is combined with caffeine, as it is in many diet pills promoted as “ephedra free,” it can raise the heart rate and the blood pressure as it did in the 10 healthy subjects who were between 19 and 42.

The researchers had not expected to see a significant increase in blood pressure in a study with only 10 people and, thus, regarded the finding as “amazing.”

In the study, participants were given the ephedra-free supplements Advantra Z, which contains bitter orange alone, and Xenadrine EFX, which at the time of the study contained bitter orange along with vitamins and minerals and caffeine equal to two large cups of coffee. (Cytodyne, the company that makes Xenadrine EFX, no longer uses bitter orange.)

Although the Advantra Z had 15.6 milligrams of synephrine (the main active ingredient in bitter orange) and the Xenadrine EFX 2.75, only the Xenadrine EFX raised blood pressure.

According to researchers, the increase could not be caused entirely by the caffeine, because although caffeine can boost systolic blood pressure (when the heart beats), it does not affect diastolic blood pressure (when the heart is at rest).The Xenadrine EFX increased both.

Whether the blood pressure problems caused by pills are triggered by the caffeine, the bitter orange or a combination of the two, experts agree that taking the pills is probably not worth the health risk.

The F.D.A. does not require manufacturers of dietary supplements to prove that the products are safe and effective before they are sold. Adam Myers, a professor of physiology and biophysics at Georgetown University Medical Center in Washington, who recently reviewed the research on the supplement, said "There are no clinical studies that show it's an effective weight loss agent."  

Dr. Jonathan Waitman, a specialist in internal medicine and clinical nutrition at the Comprehensive Weight Control Program at NewYork-Presbyterian/Weill Cornell Hospital, said the study illustrated the risks involved with over-the-counter diet pills.

"My take-home point would be that you don't know what you're getting when you take one of these supplements," Dr. Waitman said. "There's no way for the consumer to use caution other than not to buy these at all."
]]> Citrus Aurantium, Herbal Weight Loss Ingredient, Ephedra Substitute, May Have Risks http://www.yourlawyer.com/articles/read/8455 Sat, 28 Aug 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8455
The review, published in the September issue of Experimental Biology and Medicine, found that no reliable scientific evidence supports the use of C. aurantium for losing weight. More importantly, high doses of the herb, which contains synephrine, may not be safe. Synephrine can cause hypertension, and C. aurantium also interacts with drugs in a manner similar to grapefruit juice.

C. aurantium has many of the same potential deleterious cardiovascular effects as ephedra, and it also potentially affects the metabolism of other drugs, said Adam Myers, PhD, professor of physiology and co-author of the review. The public and the medical community should be concerned about the growing use of C. aurantium without adequate data on safety and efficacy.

Since the banning of ephedra-containing products by the Food and Drug Administration, a new wave of ephedra-free herbal weight loss preparations has surfaced. Many of these products contain C. aurantium, a small, sour citrus used to flavor Curacao, Cointreau, and Triple Sec. CA has also been used in traditional Chinese medicine to treat digestive problems.

Among the points highlighted in their review, Myers and co-author Adriane Fugh-Berman, MD, associate professor of Physiology, discuss that C. aurantium, like grapefruit, contain flavonoids that affect drug metabolism and can increase blood levels of drugs, thus increasing side effects.

"The effects on drug-metabolizing systems are not identical. C. aurantium juice, but not grapefruit, increased levels of indinavir, a drug used to treat AIDS. Grapefruit juice, but not C. aurantium juice, increased cyclosporine levels. Both citruses increased levels of felodipine, a calcium channel drug used to treat high blood pressure, said Myers who directs the first Master's degree-granting graduate level program in Complementary and Alternative Medicine in the United States.

"Potential drug interactions could be serious," states Fugh-Berman, author of the 5-Minute Herbs and Dietary Supplement Consult (Lippincott Williams and Wilkins 2002). "Anyone who is taking daily medication should consult a physician before combining it with the use of C. aurantium. This and other herbal weight loss products should not be considered safe simply because they are available over-the-counter. The best way to lose weight is through exercise and diet."

Myers and Fugh-Berman encourage much more research on the effects of C. aurantium. As part of the Complementary and Alternative Medicine (CAM) Masters Program they help guide at Georgetown, Myers, Fugh-Berman, and their colleagues are focused on training scientists to address the research gaps in CAM, educating health care practicioners on the benefits and risks of CAM, and promoting critical, interdisciplinary thinking.

The second year of this pioneering graduate biomedical program has enrolled double the students as the first year of the program, demonstrating a sincere and growing interest in exploring the science behind CAM and helping to fill in missing data to determine the safest recommendations for consumers. ]]> Bitter-Orange Products Raise New Concerns http://www.yourlawyer.com/articles/read/8354 Tue, 27 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8354
Like ephedra, the stimulant is used by people seeking to lose weight. Products containing the ingredient have been widely available for a little more than a year, but already bitter orange has been linked to 169 reactions in people who took it, said a spokeswoman for the Food and Drug Administration.

The agency is monitoring reports of problems with such ephedra-free products closely and is planning studies to explore their safety, she said.

Industry observers are watching the issue with interest. "I think [the FDA] learned their lesson with ephedra, so maybe they're going to be more cautious with these first cousins," said Bill Gurley, a professor of pharmaceutical sciences at the University of Arkansas.

"How quickly they'll act, that's the key question. But at least they are looking at it."

A government ban on ephedra went into effect April 12 after years of reports and studies on its potential dangers. About 16,000 adverse events and numerous deaths had been linked to the substance, and the agency was criticized widely for not taking action sooner.

Although the FDA maintains that so- called adverse events are not considered proof of a problem, dietary supplements that garner suspicion now may be targeted for faster action.

Lawmakers press for probe

Several lawmakers have already asked the FDA to investigate the safety of ephedra substitutes and to remove dangerous products. And Sen. Richard Durbin (D-Ill.), who has expressed concern over bitter orange, is working with Sen. Orrin G. Hatch (R-Utah), a longtime supporter of the dietary supplement industry, to introduce a bill mandating that manufacturers promptly report serious adverse events related to dietary supplements.

The action by lawmakers and the FDA's interest in funding studies on ephedra-free products follow growing unease over bitter orange, the most prominent ingredient in most ephedra substitute products. The herb, Citrus aurantium, also called sour orange, Seville orange or zhi shi has a long history of use in Chinese medicine but only came to the attention of American consumers as fears over ephedra grew.

Extracts from the peel of the bitter orange contain the chemical synephrine, a substance similar to ephedra and pseudoephedrine, which is found in many over-the-counter cold remedies. Like ephedra, bitter orange may contribute to weight loss by increasing metabolism.

But while ephedra raises heart rate, respiratory rate and blood pressure, it is unclear whether bitter orange acts similarly. Some animal studies suggest similar effects, which could make the herb particularly risky for people with arrhythmias and high blood pressure.

Safety studies needed

Michael McGuffin, president of the American Herbal Products Association, an industry trade organization, said products with bitter orange and caffeine (also a stimulant) were only a potential risk in people who should avoid stimulants in general, such as people with heart problems.

But, he said, "there is also interest in the industry in adding to the weight of the science on bitter orange. We're going to have to provide a greater level of scientific data to the [FDA] and appease their concerns." There is little high-quality, scientific information on the substance's risks and benefits. Scientists are scurrying to learn more about its safety and effectiveness.

"It's almost like we're back to square one in understanding what these weight-loss products mean," said Dr. Christine Haller, a medical toxicologist at the University of California, San Francisco, who is studying bitter orange.

Determining the safety of bitter orange and other ephedra-free products may be complicated, because most contain multiple ingredients such as bitter orange, caffeine and other herbs, Gurley said. He's about to start a study examining heart rate, blood pressure and the heart's electrical activity in people taking a product containing bitter orange and caffeine.

"What we do know about synephrine is that, pharmacologically, it's similar to ephedra," he said. "Ephedra and caffeine boost each other's side effects. By themselves, they're fairly innocuous." Haller, a consultant for the California Poison Control Center, is comparing the effects of a bitter orange extract, a multiple-ingredient supplement containing bitter orange and a placebo.

She said the agency had received some reports of agitation, nervousness and high blood pressure related to bitter orange products.

A few reports of serious problems related to the herb also have been published, including a case in the March issue of Annals of Pharmacotherapy describing a heart attack in a 55-year-old woman who had taken 300 mg a day of bitter orange in a product called Edita's Skinny Pill. The woman had no history of heart disease, high blood pressure or high cholesterol, but she did smoke, a risk factor in heart attacks. ]]> Herbal Supplements Can Damage Kidneys, Liver http://www.yourlawyer.com/articles/read/8221 Sun, 04 Jul 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8221
According to doctors at UT Southwestern Medical Center at Dallas, substances such as bitter orange, germander, jin bu huan and usnic acid ingredients in weight-loss products have been associated with kidney and liver problems.

A number of herbal preparations have been implicated in causing liver damage, some even leading to the need for a liver transplant or to death, says Dr. William Lee, professor of internal medicine and an expert in digestive and liver diseases. Herbal products are not under any specific supervision by the Food and Drug Administration, so there is no quality control, no proof of efficacy and no tests of safety.

The ban on ephedra, which had been linked to more than 150 deaths and dozens of heart attacks and strokes, was the governments first for a dietary supplement. New manufacturing and labeling regulations for dietary supplements are expected later this year, according to the FDA.

The herbal industry is largely satisfying a need for self-remedies for patients who are unwilling to seek conventional medical attention or are wary of doctors, says Dr. Lee. Most supplements are indeed harmless and only injure the pocketbook. Many people, however, take these compounds in any amount, never limiting themselves to what is advised regarding dosing. ]]> Health Canada Serious Warning Against Use of Thermonex Capsules http://www.yourlawyer.com/articles/read/8119 Tue, 01 Jun 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8119
Thermonex contains synephrine, which is similar to ephedrine and may have similar adverse effects such as hypertension and cardiovascular toxicity. These adverse effects could lead to stroke, heart attack and/or death. Health Canada has previously advised consumers against the use of ephedrine-containing products, especially those containing caffeine and other stimulants*. Thermonex also contains high levels of the stimulant caffeine and other ingredients which increase the effects of synephrine. Many other health products advertised for weight loss, and containing "bitter orange extract" may also contain synephrine.

Thermonex is manufactured by BSN Inc. in the U.S. While it is not yet known if this product is currently being sold in Canada, shipments of Thermonex have been refused at the Canadian border. Health Canada has issued a Customs Alert to prevent shipments of this product from entering the country. Should Health Canada become aware of this product being sold in Canada, appropriate action will be taken to ensure its removal from the market.

If consumers have concerns about Thermonex or similar products that contain synephrine, especially those containing caffeine and other stimulants, they should consult a pharmacist or physician.

Health Canada advises consumers, particularly those with pre-existing conditions such as heart disease, hypertension, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma and pheochromocytoma (a type of adrenal gland tumour), to consult a physician prior to the use of any product marketed for weight loss, body building and increased energy.]]> Battle Rages Over Bitter Orange http://www.yourlawyer.com/articles/read/8044 Tue, 18 May 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/8044
The Food and Drug Administration banned ephedra earlier this year because of deadly side effects and is now concerned about bitter orange.

Bitter orange has the botanical name citrus aurantium and is derived from the seville orange. Bitter orange is in many foods, including some orange marmalades, but in supplements, its active ingredient synephrine is much more concentrated.

Synephrine is in the same family as ephedrine and other stimulants.

"They stimulate your cardiovascular system, raise your heart rate, raise your blood pressure, stimulate your central nervous system," said Nancy Metcalf, senior editor of Consumer Reports.

For people trying to lose weight, bitter orange has become a popular replacement for ephedra, which the FDA pulled from the market in April after being linked to heart attacks and strokes and 155 deaths. It also was linked to the death of Orioles pitcher Steve Bechler in February 2003.

Consumer Reports placed bitter orange on its hit list of dangerous supplements still at large.

"Here's the problem with synephrine it's almost never been studied in people," said Metcalf. "There are animal studies. People who go on it lose weight, but with bad cardiovascular results."

Mark Blumenthal is the founder of the American Botanical Council, a nonprofit organization that tries to educate doctors, the media and the public about herbs. When it comes to bitter orange, he said it's been unfairly judged.

"Because something is chemically similar doesn't mean that it has the same pharmacological or biological action in the human body," said Blumenthal.

Blumenthal points to the fact that bitter orange has been judged by the FDA to be generally recognized as safe as a food additive.

"Bitter orange has been used in Chinese medicine for hundreds, maybe thousands of years," he said. "It does have an effect when taken orally. The question is how much."

There have been some reports of adverse effects in people taking bitter orange, but companies who use it don't have to report those negative reactions to the FDA it's all voluntary.

Blumenthal is waiting for the results of a scientific review of all available research on bitter orange. In the meantime, he said the warnings on bitter orange labels should be sufficient.

"If people heed the warnings and use the products in a responsible manner, by and large, most of these products are very safe," said Blumenthal.

But Metcalf thinks weight-loss supplements should be avoided altogether.

"Either they're ineffective in which case you're wasting your money or if they work, it's a stimulant and a stimulant is endangering your health," said Metcalf.

There is a bill now before the Senate which would give the FDA the authority to make supplement companies report bitter orange adverse events. The bill would also put stimulants in a different category, so they'd have a pass some sort of safety screen before they're brought to the market. ]]> 12 Dangerous Dietary Supplements Identified By 'Consumer Reports' http://www.yourlawyer.com/articles/read/7888 Wed, 07 Apr 2004 00:00:00 -0700 http://www.yourlawyer.com/articles/read/7888
In a report in the May issue, the consumer publication found a dozen herbal supplements some banned in Asia, Europe and Canada but widely available in the USA that may cause cancer, kidney or liver damage and even death.

They include:

Aristolochia, linked to kidney failure and cancer.

Yohimbe, linked to heart and respiratory problems.

Bitter orange, similar to ephedra, the banned weight-loss supplement believed responsible for 155 deaths nationwide.

The researchers also cited chaparral, comfrey, germander, kava and scullcap, all of which are known or likely causes of liver failure; lobella because of its impact on the heart; and pennyroyal oil because of possible liver, kidney and nerve damage.

Two of these supplements have already been acted on by the U.S. Food and Drug Administration. Organ/glandular extracts are affected by FDA restrictions on the use of bovine materials in supplements because of the risk of mad cow disease.

And in March, then-FDA commissioner Mark McClellan warned companies to stop selling the bodybuilding supplement androstenedione (andro).

"A lot of people believe that herbal supplements are safe because they've been used for years in traditional medicine," says senior editor Nancy Metcalf. But "when they went looking for problems in China, they found plenty of them."

The findings highlight the lack of oversight. A 1994 law, the Dietary Supplement Health and Education Act, has been seen as tying the hands of regulators because it requires the FDA to allow the sale of any supplement it cannot prove is unsafe.

But a recent report by the National Institutes of Medicine says flat out that the FDA doesn't need direct evidence of human harm to stop sales of dangerous supplements. It's enough to establish the danger using animal or test-tube studies, or even with reports of problems from similar products.

Manufacturers should be required to report side effects and include a phone number on packaging for consumers who want to do so, the panel said.

Meanwhile, the FDA has sent warning letters to 16 dietary-supplement distributors found to be making false and misleading claims on the Internet for weight-loss products. Many claim to block starch, carbohydrates and fat calories, creating weight loss without any lifestyle changes.

Not all supplements are snake oil, Consumer Reports says. It identified three that show possible benefits and low risks, including saw palmetto for benign enlarged prostate, glucosamine and chondroitin for arthritis, and fish oil capsules for heart health.]]> Consumer Reports Warns Of Herbal Supplement Dangers http://www.yourlawyer.com/articles/read/7883 Fri, 02 Apr 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7883
The Food and Drug Administration estimates more than 30,000 different dietary supplements on the market. What do we really know about their safety? Not enough, according to Consumer Reports.

Most supplements on store shelves come without safety testing or warning labels.

Beverly Hames is proof that what you do not know can hurt you. In the early 1990s, she took supplements containing aristolochic acid for back pain. She wishes she knew then about its potential side effects.

"I was told that these herbs are safe, they're natural and they've been used for hundreds of years," Hames said.

After taking aristolochic acid, Hames had to have a kidney transplant. She agrees with Consumer Reports in saying that it should not be sold.

"Aristolochic acid causes kidney failure and that's not all. It's a potent carcinogen. This herbal ingredient is known to cause cancer," said Ronni Sandroff of Consumer Reports

The supplements do not warn about potential risks and aristolochia may not even be listed on labels as an ingredient.

"On [one] bottle it's labeled as aristolochia fruit. On other bottles, we've seen it's called wild ginger," Sandroff said.

Consumer Reports warns it is not the only dangerous supplement for sale.

"You may think the Food and Drug Administration is watching over dietary supplements. In reality, the government has very little control. People taking supplements in many cases are essentially guinea pigs," said Jim Guest of Consumer Reports

Unlike prescription and over-the-counter drugs, supplements are not closely monitored.

Drug manufacturers have to prove a drug is safe and effective before it is sold and the label must list potential side effects.

No safety or effectiveness tests or warning labels are required for supplements. The industry says current regulations are adequate.

Many supplements will not hurt users, but Consumer Reports believes with so little government oversight, people should avoid most of them.

"Aside from vitamins and minerals, we've found very few where there's adequate evidence the supplement would do any good and poses little risk," Guest said.

Consumer Reports and Hames want more regulation.

"This absolutely did not need to happen to me or to anyone else who has ingested this herb," Hames said.

Consumer Reports says dietary supplements that contain aristolochic acid are the most dangerous, but they name 11 others to avoid. They include comfrey, androstenedione, chaparral, germander, kava, bitter orange, organ & glandular extracts, lobelia, pennyroyal oil, scullcap and yohimbe.]]> Investigation Uncovers Most Dangerous Supplements http://www.yourlawyer.com/articles/read/7882 Thu, 01 Apr 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7882
The potentially dangerous effects of most of the products have been known for a decade, yet they still are being sold, according to the magazine.

Among them are androstene, a popular sports-enhancing supplement now banned by athletics associations. Consumer Reports said it can increase cancer risk and lower HDL cholesterol.

The investigation also found another popular supplement, kava, can cause severe liver problems, even death.

The other 10 herbal supplements are:

Snakeweed or snake root
Comfrey
Chaparral
Germander
Bitter orange
Extracts from brain or adrenal glands
Lobelia
Pennyroyal oil
Scullcap
Yohimbe ]]> Bitter Orange Side Effects Lawyer Epedra Free Lawsuit http://www.yourlawyer.com/topics/overview/bitter_orange Thu, 01 Apr 2004 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/bitter_orange DOWNLOAD OUR BITTER ORANGE INFORMATION PACKAGE

Injured by Bitter Orange?

On July 27, 2004, the FDA announced that it is going to start looking into the safety of alternatives to Ephedra. One product that has filled the market niche of Ephedra is Bitter Orange (generic name: Citrus Aurantium). It contains Synerphrine, which brings about stimulation similar to Ephedra and many believe that it is as dangerous as Ephedra.

Supplement manufacturers are already gearing up to replace Ephedra with supplements like bitter orange. An FDA spokesman said Bitter Orange has been associated with seven deaths and 25 adverse reactions.

Bitter orange is now used in a new generation of herbal diet pills that are being marketed as safe alternatives to the banned Ephedra. Popular products include Xenadrine EFX and Metabolife's Metabolife Ultra.

Metabolife declined to answer questions about Metabolife products that contain bitter orange or whether the company has conducted any product safety tests.

Bill Gurley, a professor of pharmaceutical sciences at the University of Arkansas, said it is too early to declare bitter orange safe. The substance is chemically similar to Ephedra and could pose similar health risks, he said. "Based on the pharmacology of some of these compounds and the few case reports starting to come out, it doesn't look good," Gurley said.

A government ban on Ephedra went into effect after years of reports and studies on its potential dangers. About 16,000 adverse events and numerous deaths had been linked to the substance, and the agency was criticized widely for not taking action sooner.

Several lawmakers have already asked the FDA to investigate the safety of Ephedra substitutes and to remove dangerous products. And Sen. Richard Durbin (D-Ill.), who has expressed concern over bitter orange, is working with Sen. Orrin G. Hatch (R-Utah), a longtime supporter of the dietary supplement industry, to introduce a bill mandating that manufacturers promptly report serious adverse events related to dietary supplements.

Researchers say the supplement may cause cancer, severe liver or kidney damage, heart problems, or even death. Supplements do not have to undergo the strict trials and regulations that ethical/prescription drugs do.

If you or a loved one took Bitter Orange and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>