How Safe Is Weight-Loss Supplement Xenadrine?

In May 1998, best friends Kimberly Brooks and Monique Ishikawa were driving across the Canadian border when the car behind them hit their vehicle at 100 mph, turning it into a fireball.

Both Vancouver teens died at the accident scene. The driver who hit their car, Julia Campagna, was charged with manslaughter. But in September 1999, a British Columbia Supreme Court Justice ruled that Campagna was "not criminally responsible by reason of mental illness."

Campagna walked away from the charges scot-free. Her lawyers argued that the herbal weight loss supplement Xenadrine made her psychotic. Campagna claimed she was delusional, hearing voices from her car radio that were urging her to drive faster.

'A Speed Cocktail?'

Campagna and the families of her victims are now suing Cytodyne Technologies, the manufacturer of Xenadrine, claiming that the main ingredients in the capsules — ephedrine and caffeine — can be a dangerous combination.

"We believe that when you take an ephedra-based product, mix it with some other synergistic chemical like caffeine or other components of these products, you're in essence making a speed cocktail," said Mark Scheer, the attorney for the families.

Psychiatric journals have documented other cases of people who took ephedra and caffeine products, who showed symptoms of mental problems.

Cytodyne attorneys deny the product causes psychosis. The product's label warns, "do not use if you are at risk or being treated for psychiatric disease."

They also claim that Campagna had a history of mental illness and should not have taken Xenadrine.

"It is our view that no person who has a psychiatric disorder should take a stimulant without the advice of their physician," said Brian Malloy, an attorney for Cytodyne.

Health Complaints Made to FDA

Xenadrine is one of dozens of popular weight-loss products advertised nationwide that contain ephedra, caffeine and other herbal ingredients. Since 1994, the Food and Drug Administration has received 1,400 complaints of health problems —: high blood pressure, strokes and heart attacks — from people who claimed they took ephedra-based products.

The FDA says that those include reports of 80 deaths.

Trying to Lose Five Pounds

Pat and Harold Givens' daughter, April, died from a brain hemorrhage at age 21. She had been taking an ephedra and caffeine product called Youngevity Fat Metabolizer in an effort to lose five pounds.

"It's like playing Russian roulette. Some people can take it and some may not," Pat Givens said.

The Youngevity bottle warns that exceeding the recommended dosage may cause serious adverse health effects, including heart attack and strokes.

The Givens are suing the supplement manufacturer, claiming the product caused their daughter's stroke. In the lawsuit, they say that April was perfectly healthy and that she took the correct dosage.

"They advertised this as a natural safe product without giving you any clue that if you're a healthy normal person that there is a danger in taking this product," Pat Givens said.

Youngevity, the company that markets the product, wrote, "Fat Metabolizer 2001 Plus is safe and we are confident its safety will be established at trial."

Some studies show ephedra may also affect blood pressure.

"People could be taking this and it may raise their blood pressure. They don't know their blood pressure is raised and that's not a safe situation," said Dr. Louis Aronne, a diet doctor.

Label Provides Warnings

Xenadrine's label warns against taking the supplement if you are at risk for or being treated for any of these 14 ailments: high blood pressure, liver problems, thyroid problems, diabetes, pernicious anemia, nervousness, anxiety, depression, seizure disorder, cardiac arrhythmias, stroke, pheochromocytoma, prostate enlargement and psychiatric disease.

It also warns not to exceed the recommended dosages. Most ephedra weight-loss supplements have similar warnings.

Dr. Carlon Colker, an expert on natural supplements, conducted a study funded by Xenadrine's manufacturer. He said the product is not a health risk for most people.

"This is a safe product it's safe to take and as long as you heed the warning label and read the directions carefully and I want to emphasize that because if you don't read the labels you open a Pandora's box," Colker said.

But another study, funded by the ephedra industry, raised serious safety questions. A St. Lukes-Roosevelt Hospital Study in New York looked at 35 healthy people who took ephedra. Eight dropped out due to side effects that included heart palpitations, chest pains and high blood pressure. Nearly one out of four quit the study before it ended.

Yet the ephedra industry issued a press release claiming that ephedra is safe and effective, and gave no mention of the adverse side effects. Dr. Carol Boozer, who is with the Obesity Research Center at St. Luke's, declined Good Morning America's request for an interview to talk about safety questions raised by her study.

Boozer said she was too busy working on a new study funded by a company that makes ephedra weight-loss products.

The ephedra industry says there are 20 studies that prove ephedra and caffeine products are safe.

"There are people who shouldn't take it, but there is a significant portion of the population that can gain benefit from the use of ephedra as long as they follow the guidance for the products they are taking," said Dr. John Cardellina, an ephedra industry spokesman.