On February 17, 2003, 23-year-old Baltimore Oriole pitcher Steve Bechler died of multiple organ failure secondary to heatstroke while at spring training. He was 6’2” tall and 239 pounds. At the time, he had been using Xenadrine RFA-1, an ephedra-based weight loss product.
Bechler was working out in extremely hot weather with heavy clothing in an attempt to lose weight. He also had a number of risk factors which should have discouraged him from using the product. A medical examiner found ephedra contributed to the deadly heatstroke where Bechler’s body temperature soared to 108 degrees.
Bechler’s wife instituted a $600 million dollar lawsuit against the product manufacturer Nutraquest Inc. (formerly known as Cytodyne Technologies), which filed for bankruptcy in October 2003. Several lawsuits against the company are in mediation discussions.
Now, according to Newsday.com, a settlement has been announced wherein Nutraquest, its owner, and three related companies have agreed to pay almost $1 million and refrain from making unsubstantiated claims in their advertising.
Nutraquest states that it stopped selling ephedra-based products in 2003 because they were no longer profitable. Although the company claims 10 clinical studies have proven their products are safe and effective when used as directed, it settled the case “to avoid the uncertainty and cost of litigation.”
Ephedra is a stimulant containing ephedrine, an herbal “remedy” often used for weight loss, increased energy, and to relieve the symptoms associated with asthma, congestion, hay fever and allergies, and the common cold. (Ephedrine-containing products may list any of the following ingredients on their labels: ma huang, Chinese Ephedra, ma huang extract, Ephedra, Ephedra Sinica, Ephedra extract, Ephedra herb powder, Sida Cordifolia, or epitonin.)
Ephedra is a shrub-like plant that is found in desert regions in central Asia and other parts of the world. The main active ingredients in ephedra are the alkaloids ephedrine and pseudoephedrine.
Ephedra, which is or has been used in a wide array of products, has been accused of causing adverse reactions including heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, neuropathy (nerve damage), myopathy (muscle injury), palpitations (rapid heart rate), hypertension (elevated blood pressure), memory loss, insomnia, nervousness, tremors, seizures, respiratory depression, and even death.
While most of the products containing ephedra include only the recommended or otherwise permissible amounts of the supplement, some of the products, such as those designed for weight-loss and body building, often contain unsafe amounts of the substance, are used in unsafe concentrations, are used under conditions which greatly increase the risk of injury, or are taken by people who have one or more risk factors which made the use of Ephedra extremely dangerous.
The likelihood of suffering serious health problems increases as the exposure to ephedra-containing products increases. However, even short-term use at increased levels, or under adverse conditions, or by those with known risk factors, may prove to be even more dangerous. Sudden “jolts” of ephedra in high dosages may result in heart attack, stroke, seizure, or death.
As a result of the efforts of Health Canada to stop the improper use of ephedra, the sale of Ephedra products was banned completely in Canada in January 2002.
In October 2002, the FDA announced that it was stopping imports of “Yellow Jackets,” an herbal amphetamine product which contains ephedra among other stimulants.
This action was likely a response to the death of a teenager who died after taking Yellow Jackets. The FDA claimed that there did not seem to be any legitimate use for this product and that it was being marketed to consumers as an alternative to cocaine and other “street drugs”.
In February 2003, the Department of Health and Human Services (HHS), working in conjunction with the FDA, announced that they were finally going to take action to protect Americans from potentially serious risks associated with products containing ephedra. HHS and the FDA stated that they would make information concerning the health risks associated with Ephedra more readily available to the public in order to support new restrictions on Ephedra-containing products.
In addition, they demanded that new warning labels, which accurately explain the risks associated with ephedra use, appear on any products which continue to be marketed. They also sought to eliminate false or misleading advertising associated with the substance (as in the case of Yellow Jackets and energy-boosting products which promise enhanced athletic performance).
The results of a RAND Corporation study were perhaps responsible for this change in FDA and HHS policy as these results illustrated just how harmful ephedra can be when used both properly and improperly.
The results of the study listed about 16,000 adverse side effect reports including two deaths, four heart attacks, nine strokes, one seizure, and five psychiatric cases. The report also concluded that while ephedra-products make up less than one percent of all dietary supplements sales, these products account for 64% of adverse events associated with dietary supplements.
As a result of these findings, the FDA sent warning letters to more than two dozen firms marketing dietary supplements that contain ephedrine. The FDA also proposed a new warning label which illustrates the serious health risks associated with ephedra and the heightened risk of these health conditions when the supplement is taken in unsafe dosages, with strenuous exercise, and with other stimulants such as caffeine.
Notwithstanding efforts to restrict the sale of ephedra-based products and to prohibit unsubstantiated advertising claims, young people and athletes often risk serious injury or death by taking unsafe amounts of the supplement without proper medical monitoring.
As discussed above, on February 17, 2003, Steve Belcher died of multiple organ failure secondary to severe heatstroke while using an ephedra based weight loss product in an inappropriate way and probably in unsafe amounts.
On November 21, 2002, Johnny Perry, a 30-year-old strongman (6’5” and 375 pounds) died shortly after finishing among the top qualifiers in the World’s Strongest Man competition. Perry, who also used steroids, was known to “get wired” before a competition by taking 5 or 6 capsules of Ephedra.
In May of 2003, following the death of a 16-year-old boy in Illinois who ingested Ephedra in order to help him make the football team, a nationwide class action lawsuit against Metabolife and other manufacturers of Ephedra-containing products was commenced. As a result of this lawsuit, Illinois completely banned the sale of Ephedra.
Many sports organizations such as the NCAA, the NFL, and the International Olympic Committee have already banned Ephedra while others are considering similar bans.
In addition, General Nutrition Centers (GNC) announced that it will no longer sell Ephedra-containing products due to the overwhelming reports of adverse health events. Many of the manufacturers of products which had included Ephedra or one of its derivatives or associated compounds have reformulated their products to exclude those substances. Their advertising campaigns clearly announce their products are now “Ephedra free.”
Although Ephedra was finally banned by the FDA in April 2004, the ban was lifted by a federal judge.