Yourlawyer.com (Xenadrine News) http://www.yourlawyer.com/topics/overview/xenadrine Sat, 21 Nov 2009 01:51:49 -0800 pixel-app en Studies show diet pills still pose risks http://www.yourlawyer.com/articles/read/11482 Mon, 13 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11482
Although the drugs were widely effective at suppressing appetite, patients began to complain of rapid heartbeats and unpredictable mood swings. Doctors also began to notice patients’ blood pressure elevating to dangerous levels.

Since that time, there have been hundreds of prescription weight loss drugs introduced to the public and hundreds of recalls due to dangerous side effects. Many of these drugs, although containing different ingredients, have been associated with the same health risks, including high blood pressure, severe heart damage, kidney damage and stroke.

In the mid-1990s, there was an explosion of all-natural, over-the-counter, weight loss pills. With people feeling safe in the terms used to describe these pills, the over-the-counter diet pill sales peaked for several years. Studies done on many of these pills have shown they too can cause serious health problems regardless of being natural.

Then, in 2004, the FDA banned ephedra, which is an all-natural substance used in many popular weight loss pills. The ban was issued after 155 people died while on the supplement. Many diet pill manufactures are now looking for new suppressants and have turned to citrus aurantium.

Citrus aurantium, also known as bitter orange, is believed to have similar effects as ephedra and is now one of the most widely used dietary supplements. Citrus aurantium contains a compound called synephrine that, like ephedra, stimulates the central nervous system and may boost metabolism.

Manufacturers claim citrus aurantium safely boosts energy while suppressing appetite and increasing metabolic rate and caloric expenditure. However, Dr. Christine Haller, a clinical pharmacologist at the University of California Medical Center in San Francisco, questioned the safety of the substance in two supplements, Advantra Z and Xenadrine EFX, in a 2005 study.

For the study, Dr. Haller and colleagues examined participants randomly given Advantra Z, Xenadrine EFX, or a placebo on three separate occasions. They measured participants’ short-term cardiovascular responses and found compared with the placebo condition, Xenadrine EFX boosted blood pressure up to 10 points, while Advantra Z did not appear to affect blood pressure.

Both products elevated heart rates for as long as six hours after taking the supplement. Dr. Haller says the fact that Advantra Z contains only bitter orange extract as its active ingredient suggests it alone does not raise blood pressure; rather, the mixture of bitter orange extract, caffeine and various herbs contained in Xenadrine EFX is what affects blood pressure.]]> Study Suggests Ephedra-Free Supplements May Not Be Risk-Free http://www.yourlawyer.com/articles/read/10645 Sun, 11 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10645
The findings are published in this month’s issue of the American Journal of Medicine.

Both of the weight loss products tested contain Citrus aurantium, or bitter orange extract, a substance that is rapidly replacing ephedra in dietary supplements since its ban by the FDA last year due to concerns about severe health effects of the herbal supplement.

(Although a federal judge lifted the ban, ephedra has gradually been phased out by many supplement manufacturers concerned with potential civil liability for injuries and deaths blamed on the supplement.)

In the first clinical study of the effects of these newly formulated dietary supplements, researchers monitored blood pressure, heart rate, moods, and emotions of 10 healthy adults.

Single doses of both Xenadrine EFX and Advantra Z caused increased heart rate among those tested. Xenadrine EFX also increased blood pressure and alertness. Neither product showed a serious effect on mood.

Researchers found that while Advantra Z contains only bitter orange, one dose of Xenadrine EFX has many other ingredients, including as much caffeine as found in 3 cups of coffee.

They concluded that the increased blood pressure Xenadrine EFX caused did not come from the caffeine alone, but was probably due to the combination of other ingredients of the supplement.

According to Christine Haller, MD, UCSF assistant professor of medicine and lead author of the paper: "These findings indicate that ephedra-free dietary supplements could have some of the same adverse health effects associated with previously available ephedra products, such as Metabolife 356 and Ripped Fuel."

Until longer-term studies of these weight loss supplements are conducted, doctors should alert patients to the potential dangers of ephedra-free dietary supplements and should monitor blood pressure in people who choose to use them.]]> Commentary: Ephedra: One Down, More To Go http://www.yourlawyer.com/articles/read/7430 Wed, 14 Jan 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7430
In the face of growing concern, the $4 billion herbal supplement industry has been flooding the shelves of health-food stores with ephedra-free products that purport to boost athletic performance and weight loss.

Trouble is, says Woosley, "it is very likely that the substitutes for ephedra are going to be just as toxic." And without a change in the law, it would take many years for the FDA to amass enough evidence to take each one of them off the market if problems arise, just as with ephedra.

Paranoid much? Get smart about different kinds of attacks, plus keeping yourself safe and nine famous hacks.

Ephedra was banned because the active ingredient in ephedra supplements, ephedrine, causes blood pressure and heart rate to rise. Chemically similar to amphetamines, or "speed," ephedrine is used in products that have been linked to heart attacks, strokes, and deaths. Those effects are even more pronounced when combined with caffeine, yet many so-called natural dietary supplements that include ephedrine also contain the stimulant. That's one reason why over-the-counter drugs, regulated separately by the FDA, cannot combine the two.

The new products, such as Diet Fuel Ephedra Free from Twinlab Corp., Metabolife International Inc.'s Ultra, and Cytodone Technologies' Xenadrine EFX, typically substitute an herb called bitter orange. But bitter orange contains synephrine, a chemical kissing cousin of ephedrine that produces some of the same effects. Already, there are reports of adverse reactions to the new ephedra-free products, says pharmaceutical sciences professor Bill J. Gurley at the University of Arkansas. The ephedra ban is "like putting your finger in the dike when the river is overflowing," says Dr. Marvin M. Lipman, chief medical adviser for Consumers Union.

Industry representatives concede that bitter orange can raise blood pressure and heart rates, yet insist it is safe. "We have reviewed all available publications," says Metabolife spokesperson Jan Strode. "None indicate any significant side effects in normal individuals." Twinlab and Cytodyne did not return calls.

NO DATA, NO ACTION. How did we get into this mess? Blame Congress for a 1994 dietary supplement law. Makers don't have to show that a product works or that it's safe. They don't even have to report problems to the FDA, as drugmakers must. To order a product off the market, the agency must prove that it poses "imminent harm" a standard met only by a sudden, dramatic rise in injuries or deaths or "unreasonable risk." To make its case, the FDA must rely largely on doctors' or consumers' voluntary reports. But under 1% of problems are reported, and those reports are often vague.

That's why it took years for the FDA to build its case against ephedra. It had been trying to regulate the products since the mid-1990s, only to be undercut by Congress and the courts for lacking sufficient evidence. Now, the FDA has reports of more than 16,000 adverse events, including at least 155 deaths. And lab results show that ephedra can cause heartbeat changes associated with higher risk of heart attacks. Even so, there's no guarantee that the agency will win an expected court challenge, though a loss might ultimately give it more authority. "If the judge says we don't have enough evidence, it's pretty clear the FDA is out of the game and Congress has to change the law," says one top official.

With the potential threat of harm from ephedra-free products, leaving the law unchanged is too great a risk. But unless the FDA can argue that the synephrine in bitter orange is chemically close enough to ephedrine to be covered by the coming ban, the agency will find it tough to restrict. "A lot of people will die waiting to get it off the market," Woolsey says. If that happens, the ephedra ban would be little more than a hollow victory. ]]> Diet Supplement Suit Only A Start, Says N.J. http://www.yourlawyer.com/articles/read/6382 Sat, 02 Aug 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6382
State Attorney General Peter Harvey said that consensus spearheaded the recent lawsuit filed against New Jersey diet pill manufacturer Cytodyne Technologies Inc., whose ephedra-based Xenadrine has been shown to cause serious side effects.

"We're taking a very close look at the diet supplement arena," Harvey said. "We have to look at it because if we don't, no one else will."

Xenadrine made headlines recently with the wrongful death lawsuit brought on behalf of the estate of Baltimore Orioles pitcher Steve Bechler, who died during a spring training workout after ingesting Xenadrine RFA-1.

For Harvey, the state's pending suit is more about accountability than bank accounts.

"It's not our objective to put anybody out of business," Harvey said, adding that he hopes "responsible" health food stores will halt Xenadrine sales. "Money isn't really our objective, our objective is full disclosure to the public."

Opening the floodgates

Harvey said the suit, which was filed in Superior Court in Monmouth County, is the beginning of an ongoing initiative against the billion-dollar weight loss industry.

"Our first action is against Cytodyne," Harvey said. "We expect to file more actions against other companies that also offer ephedra on the basis of unsubstantiated research and unsubstantiated claims."

Ephedra is a stimulant derived from the Chinese herb ma huang, which has been shown to cause dizziness, anxiety and increase blood pressure and heart rates.

Representatives from Cytodyne could not be reached for comment.

Time for safety?

Dr. Craig Wax, a Harrison Township board-certified family physician and alternative and complementary medicine expert who hosts "Your Health Matters" on 89.7 Rowan Radio, said it's about time government got involved in the diet supplement business.

"My hope is that there will be more regulation of the assurance and quality content of the safety and efficacy of these over-the-counter supplement products," Wax said. "Not necessarily that they should be restricted in their sale, but the companies should be responsible and liable for the claims they make and their product safety."

As it stands now, Wax said, food supplement manufacturers do not have to prove safety or effectiveness and have been almost unrestricted in health claims.

"I'd like to see this action wake up the supplement industry so that they can be accountable and reputable in their business practices," Wax said.

The price of an endorsement

A handful of New Jersey doctors are also listed as defendants in the state's Cytodyne suit for allegedly signing testimonials backing the product.

While not unheard of, Jay Feinman, a law professor at Rutgers School of Law, said naming doctors in a suit is certainly uncommon.

"The attorney general goes after not just the company, but the doctors," Feinman said. "That's an interesting sort of factual incident in this case."

In the Cytodyne case, Harvey said doctors played a major role in misleading the public with bogus assertions.

"It's OK if you don't make affirmative claims based on clinical research," Harvey said. "It's quite another thing to also have doctors endorse a product when they have no expertise in this particular area."

Unlike the doctors named in the state's suit, Dr. Kathryn Lambert, a sports medicine specialist with University of Medicine and Dentistry of New Jersey, said she would not recommend that any of her patients take diet supplements and questioned why other doctors would back the product.

"People in the medical community try to advocate to never use these products," said Lambert, an assistant professor of Clinical Family Medicine. "I certainly can't think of any colleague who would do that for a dangerous product such as ephedra."

Product warranties

Just like with new automobiles, Feinman said, consumers should have the same assurances that weight loss supplements will deliver promised results.

"A drug that's made without the proper warnings is just like a car where the brakes fail suddenly," Feinman said. "If you make it such that it's unreasonably dangerous ... then the manufacturer is potentially liable."

Feinman said individuals injured by Xenadrine or similar supplements would have just as good a case if not better than the Attorney General.

"Somebody who makes a product which is potentially dangerous is going to be more concerned about their liability for personal injuries, that someone or their heirs is very likely to sue," Feinman said. "Here's an example where most people would say 'We want the tort system to work.']]> Newton Firm Never Tested Supplements, Exec Says http://www.yourlawyer.com/articles/read/6341 Thu, 24 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6341
Robert Occhifinto, president of NVE Pharmaceuticals in Newton, testified yesterday the company had not used medical professionals in the formulation of supplements containing the controversial herb ephedra. He also acknowledged serving sentences for two criminal offenses once for money laundering and another time for his dealings involving the illegal drug hashish.

NVE, meanwhile, is under investigation by the Food and Drug Administration for adding a prescription male potency substance to an over-the-counter dietary supplement, he said.

The executive appeared under oath before a House Energy and Commerce subcommittee investigating health risks associated with ephedra. The insights into the operations of the Sussex County company and its president come amid increasing scrutiny of the largely unregulated world of dietary supplements.

The subcommittee heard a defense of ephedra products from the founder of Cytodyne Technologies of Manasquan, now known as Nutraquest, and from executives of Metabolife International of California. Three former Metabolife officials refused to testify, invoking their Fifth Amendment right against self-incrimination.

Derived from the Chinese herb Ma Huang, ephedra is an adrenaline-like stimulant that affects the heart and central nervous system. Supplements containing ephedra have been marketed as weight-loss aids, energy boosters and sports performance enhancers claims some experts question.

The FDA has warned ephedra- based products pose "significant and unreasonable" health risks, including heart attacks, strokes and death, and the agency is examining ways to impose new restrictions on the supplements.

An ephedra-based diet pill made by Cytodyne was named by officials as a factor in the death of a Baltimore Orioles pitcher in February. The state of New Jersey has sued Cytodyne for making false claims regarding the supplement and a successor that does not contain ephedra. Cytodyne said yesterday the death of Steve Bechler had nothing to do with ephedra.

In 1994 Congress largely deregulated the dietary supplement industry, making it difficult for the FDA to pull products off the market. A number of companies have been charged with making misleading claims and dozens of personal injury lawsuits have been filed against supplement makers.

One of those lawsuits was filed by the parents of Sean Riggins, a 16-year-old high school athlete from Lincoln, Ill., who died of a heart attack while using Yellow Jacket, an ephedra supplement made by NVE Pharmaceuticals.

The company denies responsibility for the teen's death and is contesting the lawsuit. But Riggins' father, Kevin Riggins, told the House panel yesterday that ephedra products "are a poison that killed my son."

"The majority of companies in my opinion are illegitimate companies no more than drug pushers, because they are marketing a deadly substance and they don't care."

Occhifinto, in his prepared testimony, said: "I strongly believe in the safety and effectiveness of NVE's products. The overwhelming scientific evidence is that ephedra is safe and effective when used as directed."

The New Jersey executive also maintained the safety record of ephedra is "comparable and in some cases better than that of many over-the-counter pharmaceutical products."

But in a questionnaire he filled out for the subcommittee, Occhifinto was asked whether his company conducted studies on any NVE product including more than 80 containing ephedra. He answered "no."

Occhifinto, a high school graduate, was asked during the hearing whether he ever hired a medical professional or pharmacologist to formulate his products. He said he had not. Even though he lacks education or training, he said he was responsible for deciding the composition of scores of dietary supplements.

Rep. James Greenwood (R-Pa.), chairman of the subcommittee, expressed outrage at the testimony. He noted that after Riggins died and NVE pulled one ephedra product off the market, Occhifinto "changed the formulation of the product by increasing the amount of ephedrine and changing the name, without consulting any scientific or health experts."]]> Bechlers Widow Sues Companies For $600M http://www.yourlawyer.com/articles/read/6303 Fri, 18 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6303
Kiley Bechler and her attorney filed the suit Wednesday against Cytodyne Technologies, the company that produces Xenadrine RFA-1, and named New York-based manufacturer Phoenix Laboratories and Cytodyne president Robert Chinery as codefendants.

The suit alleges the controversial nutritional supplement was directly responsible for Bechler's collapse during a spring training workout at the Orioles' training facility in Fort Lauderdale, Fla., on Feb. 16. Bechler lost consciousness and his body temperature rose to 108 degrees, causing his major organs to fail. He died the next day.

"Steve Bechler is dead. Ephedra killed him," the plaintiffs charged in court documents, which were filed at U.S. District Court in Fort Lauderdale. The suit also alleges that the defendants disregarded the safety of consumers in the pursuit of profits from the herbal supplement, which was exempt from the scrutiny of the Food and Drug Administration at the time of the incident.

Since then, the FDA has taken steps to warn consumers about the possible dangers of products that contain ephedra (and its active ingredient, ephedrine) and estimate the substance has played a role in more than 100 deaths nationwide.

Broward County medical examiner Dr. Joshua Perper pointed to ephedra as a contributing factor almost immediately after Bechler's death, even before the toxicological report confirmed Bechler had taken three Xenadrine capsules the morning before he collapsed.

The lawsuit also names as a defendant a yet-to-be-determined company, representing wherever Bechler purchased the Xenadrine.

There never seemed any doubt that Bechler's widow, who was pregnant with the couple's first child when her husband died, would file a product liability lawsuit. The only question was who would be named in the suit and how much money would hang in the balance.

"She has every right to do that," said Orioles manager Mike Hargrove. "She lost her husband. I'm sure that the drug company will argue that it was not the fault of the product and there are others who would argue that, but here's a young lady who has been widowed. Most people would root for the underdog."

Kiley Bechler, who gave birth to a girl named Hailie on April 22, is seeking compensation for the loss of her husband and a ban on the future sale of ephedra-based products. Meiselman declined to comment on the size of the award being sought or how he arrived at the $600 million figure.

"If they determine there was negligence involved, she has a right to be compensated," said Orioles first baseman Jeff Conine.

There initially was speculation that the Orioles might be named as a codefendant, but the Bechler family never took issue with the team's handling of the situation, and workers' compensation law makes it extremely difficult to collect damages from an employer in a wrongful-death suit.

During the weeks after Bechler's death, a trade group representing several makers of ephedra-based products staged a media campaign to deflect blame for the incident to Bechler and the team. Industry advocates still insist ephedrine products are safe if used as directed, but several companies including Cytodyne are now aggressively marketing ephedrine-free versions of their most popular weight-loss products.

Cytodyne has yet to make a public response to the lawsuit, but it seems certain the defendants will point to Bechler's history of hypertension and liver problems as well as previous heat-related incidents to explain his death.

The NFL, the International Olympic Committee and several other major sports organizations have banned the use of ephedra-based products, but ephedra is not on Major League Baseball's list of restricted substances.]]> Pitcher's Widow Sues Drug Firms http://www.yourlawyer.com/articles/read/6305 Fri, 18 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6305
Kiley Bechler's suit, filed in U.S. District Court in Fort Lauderdale, seeks $600 million in damages and a ban on the sale of ephedra-based products.

The suit emphatically states: "Steve Bechler is dead. Ephedra killed him."

Named as defendants were New Jersey-based Cytodyne Technologies Inc. and Robert Chinery, its president, chief executive officer and sole shareholder. Also named were Phoenix Laboratories Inc. of New York and an unknown store where Bechler purchased the miracle weight-loss supplement Xendrine-RFA-1, a "poisonous cocktail" of ephedrine, caffeine and aspirin, according to the suit.

An autopsy showed that Bechler died of heatstroke and that ephedra was one of several risk factors contributing to his death. Investigators said he took three Xenedrine pills the day he died and hadn't eaten much for two days before his collapse.

The suit, charges the defendants "placed corporate and personal profits firmly ahead of consumer safety and recklessly endangered the welfare and well-being of a misled public." The defendants could not be reached Thursday.

Kiley and Steve Bechler were high school sweethearts who married a month after he was called up to the majors, the suit says.

In high school in Oregon, he was a star pitcher; she played on the softball team at a rival school. They wore the same jersey number: 22.

They were expecting a child and looked forward to a bright future when, the suit says, Bechler purchased the supplement and "became ensnared in the web of deceit spun by defendants."

The suit claims Chinery and his companies manipulated scientific data to dupe Bechler and other members of the public into thinking the product was safe and effective.

Bechler collapsed Feb. 16 at practice. According to the suit, he couldn't stand up; his body temperature, heart rate, blood pressure and respiratory rate rapidly increased. En route to the hospital he experienced seizures, gastrointestinal bleeding, kidney failure, liver damage and shock. His body temperature rose above 108 degrees.

The next day, Bechler went into cardiac arrest and died at age 23.

A bottle of Xenadrine RFA-1 was found in Bechler's locker, and toxicology tests showed "significant amounts" of ephedrine in his bloodstream. The Broward County Medical Examiner's Office concluded that ephedra was "a significant factor" in Bechler's death.

The suit seeks damages of $100 million on each of six counts, including wrongful death, failure to warn, negligence and misrepresentation. The case has been assigned to U.S. District Judge Paul C. Huck. ]]> Oriole Player's Widow Sues Drug Company http://www.yourlawyer.com/articles/read/6304 Thu, 17 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6304
Kiley Bechler also wants the sale of ephedra products banned, according to the lawsuit filed in U.S. District Court in Fort Lauderdale, Fla.

"Steve Bechler is dead," the lawsuit says. "Ephedra killed him."

Bechler collapsed in Fort Lauderdale during a Feb. 16 spring-training workout. His body temperature rose to more than 108 degrees, and he died the next day.

A bottle of the supplement Xenadrine RFA-1 was found in his locker, and Broward County medical examiner Joshua Perper said ephedra was a significant factor in his heatstroke death. A toxicology test confirmed "significant amounts" of ephedra led to his heatstroke, Perper said.

The lawsuit, filed Wednesday, names Cytodyne Technologies of Manasquan, N.J., which marketed and distributed Xenadrine RFA-1, as a defendant. Cytodyne president Bob Chinery and Long Island-based Phoenix Laboratories, which manufactured the supplement, are co-defendants.

In a joint statement, the companies said improper medical screening by the Orioles, not the supplement, caused Bechler's death.

"Although it is easy and perhaps overly simplistic to blame a supplement for the death, the real truth is the allegation that his death was caused by ephedrine is wholly unsupported by the facts or scientific evidence," the companies said.

"By improperly ascribing blame to a supplement and ignoring the real factors that contributed to the tragedy, such as improper medical screening by the Baltimore Orioles, efforts to prevent future or similar type tragedies will be impeded."

The Food and Drug Administration has linked ephedra to more than 100 deaths and scores of heart attacks, seizures, strokes and other significant health problems. The lawsuit says Cytodyne and Phoenix Labs failed to warn Bechler and other consumers about potential risks.

Cytodyne has stopped selling its ephedra supplement.

In May, a California judge ruled that ads for Xenadrine RFA-1 were misleading and ordered the manufacturer to pay $12.5 million to California consumers. The judge, Ronald Styn of San Diego Superior Court, said Cytodyne misrepresented research, minimized ephedra's health risks and used misleading testimonials to market Xenadrine RFA-1.]]> N.J. Agencies To Sue Diet-Pill Maker http://www.yourlawyer.com/articles/read/6272 Mon, 14 Jul 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6272
One of the products, Xenadrine RFA-1, was a top-selling weight-loss pill until it was yanked from the market earlier this year because of a controversy over ephedra, its main ingredient. The other supplement, Xenadrine EFX, does not contain ephedra.


The two agencies allege Cytodyne Technologies violated the state's consumer fraud act by using false and misleading advertisements that exaggerated benefits and downplayed risks of the pills.

The lawsuit, a copy of which was obtained by The Star-Ledger, also alleges five New Jersey doctors, paid to endorse the products, deceived consumers by giving the products a false legitimacy.

"The data we have examined tells us ephedra is dangerous, and those health risks are not being disclosed by the manufacturers," state Attorney General Peter Harvey said in an interview late Friday.

Ephedra is derived from the Chinese herb ma huang and has come under fire by critics who say it causes strokes and heart problems. It was named by authorities as a factor in the death of a Baltimore Orioles pitcher in February.

The lawsuit, which authorities intend to file today in state Superior Court in Monmouth County, seeks to stop the marketing of Xenadrine EFX, which Cytodyne began selling a year ago.

The case could mark the start of a more aggressive monitoring of New Jersey's dietary supplement industry. Many supplement makers are widely criticized for outlandish marketing claims.

An executive for Cytodyne declined to respond to specific allegations because he had not seen the complaint.

"Cytodyne stands behind the truthfulness of our advertising claims and the quality of our products," said Stephen Stern, executive vice president and general counsel of Phoenix Laboratories and Cytodyne LLC.

Last month, Cytodyne Technologies sold its licensing and marketing rights to Phoenix Laboratories, a contract manufacturer in Hicksville, N.Y. Cytodyne LLC distributes the company's products, which include sports bars.

Cytodyne Technologies was located in Manasquan until last month. Cytodyne LLC is operating out of Hicksville.

The lawsuit alleges Cytodyne misled consumers about the possibility of adverse side effects from Xenadrine RFA-1 and continues to use the same marketing tactics with the new version. Harvey said Xenadrine EFX contains ingredients that may cause the same effects as the ephedra-based predecessor.

Part of the suit focuses on magazine and Internet advertising that occurred between 1997 and this year. The suit also accuses Cytodyne of omitting and concealing information in its advertising for the new Xenadrine product.

It is not the first time advertising has landed the company in court.

Earlier this year, a California court ordered the company to pay in excess of $12.5 million to consumers who had purchased its weight-loss supplements. The court said the company's before-and-after testimonials were false and that certain studies Cytodyne used to market its products were misrepresented.

Cytodyne is just one of the companies that have profited from sales of the ephedra-based pills. In New Jersey, NVE Pharmaceuticals and TrimSpa also have heavily marketed diet pills containing ephedra.

Some estimates have put the business generated by such supplements at $3 billion a year. But ephedra has become increasingly controversial.

Baltimore Orioles pitcher Steve Bechler, 23, was using Xenadrine RFA-1 when he died during spring training in February. His body temperature had reached 108 degrees.

Bechler's death unleashed criticism of the dietary supplement companies using ephedra and the Food and Drug Administration for a lack of action to protect consumers.

The agency has maintained it does not have the power to pull dietary supplements from the market unless it can prove they are unsafe.

"We can't, in New Jersey, wait for the FDA to act," Harvey said. "The FDA has a myriad of rules and regulations. It could take years for them to take action." ]]> California Judge Rules New Jersey Firm's Ads, Claims Misleading http://www.yourlawyer.com/articles/read/6040 Mon, 02 Jun 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6040
Cytodyne Technologies was ordered to pay $12.5 million to California consumers for the claims about the pill, Xenadrine RFA-1.

The company denied the charges and said it would appeal.

Xenadrine includes caffeine and ephedra, an herbal stimulant that critics claim causes heart-related problems by increasing blood pressure in some users.

Xenadrine has been linked to the heatstroke death of Baltimore Orioles pitcher Steve Bechler on Feb. 17.

The company has stopped selling the ephedra-based diet pills and is selling an ephedra-free product.

Superior Court Judge Ronald Styn said Cytodyne's before-and-after testimonies of Xenadrine's benefits misled consumers by exaggerating individual results. Styn also took issue with advertisements that boasted of the pill's "amazing fat burning/muscle-sparing effects."

Styn said Cytodyne's president was aware that Xenadrine had not been clinically studied, although that claim was made in some of the product's advertising.

Friday's ruling ended a seven-week trial on a class-action lawsuit brought by Jason Park, a San Diego resident who purchased Xenadrine in 2001.

Cytodyne, in a statement from its headquarters in Manasquan, N.J., called the ruling "severe and inappropriate," and said that the plaintiff was neither injured nor deceived. ]]> Blagojevich Takes Care of Ephedra http://www.yourlawyer.com/articles/read/6016 Thu, 29 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6016
Both houses of the Illinois legislature unanimously supported the ban of the dietary supplement, which has been linked to over 100 deaths.

Have you ever taken a product containing ephedrine? This nutritional supplement can be quiet tempting, as it claims to safely help you lose weight and/or improve athletic performance.

Ephedra use has surged in the last decade, primarily because of the Dietary Supplement Health and Education Act (DSHEA) of 1994, which allows supplements to be sold as foods, not drugs.

These days, ephedra is being blamed for countless heart attacks, strokes, and over 100 deaths, including that of Baltimore Orioles pitcher Steve Bechler. Bechler's death has been associated with Xenadrine RFA-1, an over the counter diet supplement. Last year, six plaintiffs were awarded $4 million in damages in a verdict against leading ephedra manufacturer Metabolife. Clearly, the Food and Drug Administration (FDA) has fallen under great pressure to ban this herb and better educate the public on its potential health risks. To arm yourself, read the following information on the effects of ephedra.

You may be wondering what ephedra is. It refers to several related species of herbs that grow in the desert. The prime ingredient is an alkaloid called ephedrine. When ephedrine is chemically synthesized, it turns into pseudephedrine, which is a less potent decongestant found in many over the counter cold/allergy medications that is regulated as a drug.

You are probably curious about how the herb works. Ephedra works like a stimulant in that it stimulates the thyroid gland (that regulates metabolism), elevates blood pressure, constricts blood vessels, raises heart rate and body temperature, and suppresses appetite. One recent study also found it to cause heart palpitations, tremors, insomnia, upper gastrointestinal effects, and psychotic episodes, especially when combined with other stimulants.

In a lot of ways, ephedra imitates the effects of exercise in relation to heat production. It causes the heart to work harder. This spelled out disaster for Steve Bechler, who had a history of heart/liver problems, especially when he further intensified the stress to his body by working out in a rubber suit in the hot Florida sun.

As stated earlier, ephedra use has soared in recent years. While the International Olympic Committee, the NCAA and the NFL have banned it, the herb seems to be commonplace among athletes at all levels, both professional and amateur, from high-school age to college on up. Popularity of ephedra is in part due to the immense marketing efforts that promise weight loss and performance enhancement. Everyone is quick to jump on a product that is going to make losing weight easier or give him or her a competitive edge.

But does it work? Makers of the product are quick to cite studies of people who lose more weight while using it than those who don't. As with most stimulants, the boost in metabolism can lead to an increased caloric burn that results in weight loss. Improved performance claims however, are much weaker, with results demonstrating that athletes only improve their perception of their performance, not the actual results.

More importantly, is it safe? That depends on a number of factors including the amount of ephedra in the supplement, dosage, combinations of other supplements, and your personal health. Persons suffering from heart disease, hypertension, and thyroid disease should never take products containing ephedra. Interestingly, most government officials and scientists agree that it is dangerous enough to be regulated like a drug. Because of the DSHEA ruling, supplements don't have to meet standards for purity, content, and labeling and be proven safe before being introduced to the general public like drugs do.

Consider the fact that recent data from poison control centers revealed that 64 percent of all the negative events from herbal products in the U.S. resulted from ephedra, even though they represent less than 1 percent of sales. Adverse effects may be greatly underestimated because unlike drug manufacturers, supplement makers aren't required to report these occurrences to the FDA.

What's frightening is that kids often think that if a little bit is good for losing weight or improving performance, then more will be better. This, coupled with the fact that it's not being tested for makes it all the more appealing.

When it comes to losing weight and gaining that competitive edge, there's no magic pill. Good old-fashioned hard work and commitment still seems to be the safest, most successful way to go.]]> Judge Will Make Ephedra Weight-Loss Trial Ruling By May 23 http://www.yourlawyer.com/articles/read/5849 Wed, 07 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5849
Superior Court Judge Ronald Styn said he hopes to issue a ruling by May 23.

Brian Molloy, an attorney for defendant Cytodyne Technologies, said in his closing argument of the six-week trial that the plaintiffs presented no evidence that the advertising for Xenadrine RFA-1 was misleading.

Xenadrine RFA-1 is an amphetamine-like herb that produces slight, short- term weight loss.

In court documents filed a year ago, Cytodyne listed published studies as proof that its products are safe in reducing weight.

The plaintiffs allege that clinical studies Cytodyne cited don't substantiate advertising claims regarding the safety or performance- enhancement benefits of the weight-loss pill.

David Noonan, an attorney for the plaintiffs, told Judge Ronald Styn that Cytodyne didn't do the scientific studies on Xenadrine RFA-1 that it claimed in its advertising.

"I don't think you can fairly say you're all about the science. You're all about the advertising," Noonan said.

The attorney said Cytodyne spent between $15 million and $20 million in advertising Xenadrine RFA-1 compared to $63,000 for scientific studies.

"They needed science to generate ad copy," Noonan told the judge. "It's misleading to advertise the way that they did."

But Molloy told the judge that the plaintiffs never presented one witness to testify about what a consumer thought when reading what was written on a bottle of Xenadrine RFA-1.

The attorney said the plaintiffs failed to present a survey to show how consumers would respond to the weight loss product.

Molloy said the efficacy of the ephedra-based pill was based on "genuine science."

"There is an abundance of evidence to show the efficacy and safety of Xenadrine RFA-1," the attorney told the judge.

The class action lawsuit was filed in June 2001 by Jason Park, a La Jolla commercial pilot who bought a bottle of Xenadrine that same year.

The suit claims Cytodyne paid professional models and bodybuilders to gain weight, lose it, then show off in "before and after" photos to tout the merits of Xenadrine.

Xenadrine raises blood pressure and increases heartbeat, effects linked to a number of deaths.

The ephedra diet pill recently was linked to the death of 23-year-old Baltimore Orioles pitching prospect Steve Bechler.

In March, the San Diego City Attorney's Office joined in a separate lawsuit aimed at stopping what it calls misleading advertising involving state sales of Xenadrine RFA-1. ]]> Diet, Caffeine Pills Pose Health Risk http://www.yourlawyer.com/articles/read/5801 Mon, 05 May 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5801
Both prescription and over-the-counter drugs attract people who seek "quick fixes" to their weight problems, but neither offer permanent results, said Kelly Tappenden, a University professor of nutrition.

Because the government does not place regulations on the ingredients or use of many weight loss pills, the appetite suppressants and stimulants commonly labeled as weight loss supplements do not warn users about the potential health problems that could result from taking the drugs. Some weight loss pills cause depression, anxiety and heart problems, she said.

"Some may be effective in the short term, but if people don't exercise, then they'll gain weight again unless you take them for the rest of your life," she said.

Herbal supplements for weight loss often include caffeine, ephedra or other nervous system stimulants that could cause illness, said Don Layman, a University professor of nutrition.

The stimulant Ephedra, the most commonly publicized and widely used weight loss supplement, has been linked with illness and death, Tappenden said.

People, however, continue to use it as a "quick fix" to weight loss, she said.

The federal government stopped regulating over-the-counter supplements in 1994 following the passage of the Dietary Supplement Health and Education Act, or DSHEA, Tappenden said. The act permits drugs labeled as supplements to be sold over-the-counter without government regulation, resulting in an abundance of non-prescription dietary supplements. She said Ephedra was initially sold as a weight loss supplement for the controversial weight loss drug Fen-Phen.

Richard Price, spokesperson for the Ephedra Education Council, said over 3 billion servings of Ephedra are consumed by Americans yearly, offering an effective solution to America's growing weight problem. He said quality regulations are already in effect, and that industry standards are enforced "vigorously."

For students like Melinda Trent, senior in LAS, a supplement called Xenadrine was the solution. Ephedra, the main ingredient in Xenadrine, works with caffeine to increase thermogenesis in the body, according to their Web site. Thermogenesis is the process of converting food into heat before it can be stored as fat.

"Honestly, I did notice a difference," Trent said. "I stopped when the stories came out. If it works, it's great. But if it kills you, it's not worth it."

Ephedra can have potentially dangerous side effects, such as cardiac abnormalities, reduction of hydration status and death, Tappenden said.

"It's very dangerous and easy to get carried away," Trent said. "I told people I was doing it, so I had that accountability."

Despite an increase in energy and weight loss, Trent said she stopped taking Xenadrine because she started exercising regularly and did not think it was worth the risk.

"Doctors will just tell you to go exercise," Trent said. "Everything's a quick fix and you try it."

The company that makes Xenadrine also offers Ephedra-free weight loss pills called Xenadrine-EFX.

There are still questions regarding any weight loss drugs' safety and long-term effectiveness, Layman said.

"If anyone had a good solution, we'd all be thin," he said.

Price said Ephedra is a powerful tool in fighting obesity, offering a better alternative to the serious health risks that accompany obesity. Over 50 scientific studies have concluded that there was no serious adverse health effect from Ephedra, according to Ephedra Education Council's Web site.

Slim Mints, which have recently appeared in campus gas stations, contain the slogan "Slim Mints Lose Weight & Freshen Your Breath With One Mint" and add to the growing list of dietary supplements available to students.

"There are certainly a lot of companies that want to find the magic bullet," Layman said. "I don't think there will ever be a solution where you can eat as much as you want."

The RAND Corporation study, commissioned by the National Institute of Health, reported adverse effects of Ephedra, citing 16,000 complaints leveled by people who took the drug. Following the publication of the RAND study, the FDA sent letters to 12 weight loss firms warning them not to make misleading claims about their products' ability to treat or cure a disease or condition such as obesity.

"The problem with supplements is that you don't always get what's advertised," Tappenden said.

Price said weight loss pills are safe as long as they are taken as directed, no more than 25 mg. per serving and no more than 100 mg. per day. Many products also suggest discontinuing after a period of three weeks, he said.

As an alternative to weight loss pills, Layman said dietitians recommend a combination of calorie control, diet and exercise. Without proper weight loss techniques, the weight will come back, he said. He said he was skeptical about successful future developments in weight loss pills, and said there is no fast solution.]]> Ephedrine Comes Under Fire http://www.yourlawyer.com/articles/read/5451 Fri, 11 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/5451
Five years later, the feeling hasn't returned, she said.

Sayonara Bhattacharya blames ephedrine, a chemical in a diet supplement she said she took to enhance her workouts. She said it caused a debilitating stroke, which has forced the former model to move back to her family's home in Brazil.

"I lost my freedom, I lost everything," said Bhattacharya, 40, who is suing the Long Island-based company that produced the supplement. "If I knew ephedrine could cause the destruction of my life, I never would have taken it."

Bhattacharya's lawsuit is one of dozens across the country against companies that make weight-loss and body-building supplements containing ephedrine. In her case, the product was Ripped Fuel by Twinlab Corp., one of the nation's largest producers of nutritional supplements, with $147 million in reported revenue in 2002.

New evidence

When she filed suit in Superior Court in Morris County in 2000, Bhattacharya faced an uphill battle to prove that the popular over-the-counter product caused her stroke. But her lawyer says recent studies, combined with the high-profile deaths of professional athletes who used ephedrine, have bolstered her case.

"Before, (the company's) defense would have been, 'If it's not safe, they wouldn't let us market it,'" said David Mazie, a Livingston, N.J., attorney representing Bhattacharya. "But now we know it's not safe. There's a lot of new evidence that we can utilize."

Ephedrine is a chemical derived from the herb ephedra, also known as ma huang. It increases the blood pressure and heart rate and stimulates the central nervous system. About $3 billion worth of ephedra products are sold in the United States each year.

Last week, the U.S. Food and Drug Administration announced that every bottle of ephedra will soon bear warnings that the herb can cause heart attacks, strokes, or even death.

The FDA stopped short of an immediate ban of the herb, which some consumer groups had requested. The agency said it has not compiled enough proof of danger to stand up in court under a 1994 law that severely limits federal safety regulation of dietary supplements.

Claim disputed

Twinlab's lawyer says there's not enough proof because the herb isn't dangerous.

The recent backlash against ephedra is a product of misleading studies and media hype, said Joseph Thomas, the company's national counsel. So many people take ephedra that some are bound to die from heart attacks and strokes, but that doesn't mean the herb is to blame, he said.

"All the true science where there has been a controlled clinical study has demonstrated in every occasion that it is safe and efficacious," Thomas said.

Twinlab announced in November that it planned to stop selling Ripped Fuel with ephedrine. But the company blamed slowing sales, not concern that the product was dangerous.

High-profile deaths

Ephedra entered the national consciousness 18 months ago when Korey Stringer, a professional football player for the Minnesota Vikings, died of heat stroke after a practice. A bottle of Ripped Fuel was found in his locker, although no reports have concluded that it killed him.

Congress held hearings on the use of ephedra in diet supplements last fall.

Then, in February, baseball player Steve Bechler of the Baltimore Orioles died of heat stroke in Florida while taking the weight-loss supplement Xenadrine. The coroner's report found ephedrine in his blood and concluded that it was partially to blame.

Around the same time, a medical journal concluded that ephedrine is unsafe even when taken in recommended doses. The authors of the report in the Annals of Internal Medicine found that U.S. poison control centers reported 1,178 adverse reactions to the supplement in 2001.

Calls to ban the supplement intensified.

Last week, a study conducted at the request of the U.S. Department of Health and Human Services associated the use of ephedrine with health risks such as heart palpitations and nervous system problems. It also found no sufficient evidence that ephedrine enhanced athletic performance or promoted long-term weight loss.

Bhattacharya said she began taking Ripped Fuel in 1996 to energize her workouts at a Gold's Gym. She took about three pills a day, less than the recommended dosage on the bottle, she said.

On Dec. 18, 1998, she suffered her stroke while sitting in her living room with her 9-year-old son, who called a family friend for assistance.

"She went from being a beautiful, vivacious, healthy individual to somebody with severe handicaps who can't live on her own," Mazie said.

Her lawsuit, which says Twinlab "knew or should have known about the health risks posed by ephedrine," is scheduled for trial in September. It seeks an unspecified amount of damages. Judging from other ephedrine cases, however, she probably is seeking at least a six-figure payout.

Similar cases

A federal court in Alabama in January awarded $4.6 million in damages to four former users of the ephedra-based appetite suppressant Metabolife 356. The San Diego company that makes the supplement also faces dozens of other lawsuits.

In February, a Texas jury awarded $500,000 in a lawsuit that blamed Ripped Fuel for causing the death of a man who was taking a National Guard fitness test.

Each ephedrine lawsuit has unique circumstances and will not affect Twinlab's defense in the Bhattacharya case, Thomas said.

Her claims "make very little sense," the company lawyer said. "It's a safe and effective product."

If it is safe, Bhattacharya countered, she would still be able to care for her son on her own.

"People who are taking ephedrine need to be aware of the consequences," she said.]]> Xenadrine Ephedra Heart Attack Stroke Side Effects Attorney http://www.yourlawyer.com/topics/overview/xenadrine Fri, 11 Apr 2003 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/xenadrine DOWNLOAD OUR Xenadrine INFORMATION PACKAGE

Injured by Xenadrine?

Xenadrine RFA-1 contains Ephedra, which has been linked to dangerous side effects. According to a study commissioned by the Food and Drug Administration (FDA), Ephedra may seriously harm and can potentially kill some who use it. Ephedra is derived from an Asiatic shrub that contains ephedrine. Ephedrine is a stimulant that acts on the central nervous system to relax bronchial tubes.

Ephedra Side Effects
Products containing Ephedra can produce the following adverse reactions: heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, palpitations, hypertension and respiratory depression.

"The use of dietary supplements does pose a health risk to some people," says Neal Benowitz, MD, professor of medicine and chief of clinical pharmacology at the University of California, San Francisco. "Just because it's natural, doesn't mean it's safe." Benowitz and postdoctoral researcher Christine Haller, MD reviewed the 140 reports of deaths or injuries the FDA received related to ephedra. Researchers concluded that ephedrine use "definitely" or "probably" caused harm in 31% of the cases. Of these cases, three people died, seven suffered permanent injury and four required ongoing medical treatment. The research adds to the long-standing controversy about the dietary supplement, which is also marketed as an energy booster and treatment for respiratory illness.

However, the FDA does not currently regulate many products containing ephedra because it is labeled as a dietary supplement and thus is protected under the Dietary Supplement Health & Education Act of 1994. Pursuant to the Act, the FDA cannot regulate dietary supplements such as ephedra unless it has been proven to be unsafe. Drug companies have taken advantage of the current status of ephedrine and have attempted to produce a product with amphetamine-like qualities by mixing ephedrine with other stimulants such as caffeine.

*This site does not pertain to Xenadrine- EFX which is an ephedra free product.

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