Supplements Containing Ephedra Linked to Serious Side Effects

Jefferson City, MOThe recent Hydroxycut recall may have called into question the safety and efficacy of weight loss supplements, but the truth is that such supplements have been called into question before. In 2003, Hydroxycut, at the time manufactured by MuscleTech Research and Development, faced lawsuits related to the supplement's inclusion of the ingredient Ephedra.

Ephedra was an ingredient commonly used in weight loss supplements before it was banned by the Food and Drug Administration (FDA) in 2004. Among the companies that used Ephedra were Metabolife and Hydroxycut. According to reports, Metabolife received over 14,000 complaints of adverse events associated with the Ephedra-containing supplement. However, the FDA was not initially given that information. It was reportedly only after pressure from Public Citizen (a public advocacy organization) that Metabolife released those records.

A review of 140 reports made to the FDA regarding Ephedra-related adverse reactions, which was published in the New England Journal of Medicine in 2000, found cases of sudden cardiac death linked to Ephedra use. Many of those cases occurred in young adults who were using the Ephedra in the labeled doses. According to researchers, hypertension was the single most frequent adverse effect of Ephedra, followed by palpitations and/or tachycardia, stroke and seizures. Furthermore, "Ten events resulted in death, and 13 events produced permanent disability, representing 26 percent of the definite, probable, and possible cases [of adverse reaction linked to Ephedra]."

Meanwhile, 2 high profile deaths were reportedly linked to Ephedra. On February 17, 2003, Steve Bechler, a Baltimore Orioles pitcher, died of complications from heatstroke after a spring training workout. The medical examiner determined that Ephedra toxicity played a "significant role" in Bechler's death. In 2001, Korey Stringer, an offensive lineman for the Minnesota Vikings, died from heatstroke. The Vikings believed that Ephedra was a contributing factor in the death.

Back in 2003, Hydroxycut was the subject of a variety of lawsuits, including one filed by the state of Missouri. MuscleTech found itself facing allegations that it did not disclose safety risks associated with Hydroxycut (which contained Ephedra at the time) and that its claims that Hydroxycut was a clinically proven fat-burner were untrue.

At the time, Missouri Attorney General Jay Nixon said that even consultants who worked with MuscleTech had "serious concerns about the safety of Hydroxycut, but the company continued to market the product." He went on to say, "The disclaimers and warnings on the bottle label are so small as to be useless to many consumers, so they would not be able to read that the disclaimers would preclude use of Hydroxycut by most of the adult population of the United States, including anyone who drinks coffee or cola containing caffeine."

Part of the problem with Ephedra was that it reportedly caused an elevation in a person's heart rate and blood pressure, especially when taken in combination with caffeine. Some supplement products allegedly contained both Ephedra and caffeine, putting people at risk of serious consequences.

The Missouri lawsuit alleged that MuscleTech replaced research subjects who dropped out of studies because they could not tolerate Hydroxycut—even going so far as to conceal such subjects and not count them in the adverse effect group. Furthermore, according to the lawsuit, 1 subject was rushed to the hospital after experiencing a serious change in heartbeat, yet this incident was not included in the adverse reaction data.

Although MuscleTech denied any wrongdoing, the company eventually paid $100,000 to the state of Missouri to settle the lawsuit. The company also agreed to stop selling products containing Ephedra in Missouri and to provide refunds to buyers of the Ephedra products in Missouri.

Ephedra is still banned from dietary supplements, although it can appear in low doses in products found in nutrition centers and mall kiosks. According to a news report from Oklahoma, Ephedra is considered an herb and is not subject to FDA jurisdiction. So, people may still be ingesting Ephedra even though it has been linked to serious complications.