Ephedra Linked to 155 Deaths

Ephedra Ban Goes Into Effect This Week

WASHINGTON, D.C. — April 16, 2004 —The ban by the Food and Drug Administration (FDA) on the use of ephedra in dietary supplements went into effect this week, after surviving a challenge from two ephedra manufacturers. Used for weight control and bodybuilding, ephedra is a central nervous system stimulant that causes rapid heart beat and increased blood pressure. It has been linked to 155 deaths, and numerous cases of heart attacks and strokes.

NVE Pharmaceuticals of Newton, manufacturer of the bodybuilding supplement Stacker 2, and the National Institute for Clinical Weight Loss, manufacturer of the weight control product Thermalean, had asked for a temporary restraining order that would prevent the ban, which was announced in December, 2003. U.S. District Court Judge Joel Pisano refused to grant the order, because the companies failed to show that they would suffer “irreparable harm” if the drug was taken off the market. The manufacturers’ lawsuit may proceed at a later date, but meanwhile, ephedra may not be included in dietary supplements.

Consumer groups have criticized the FDA for taking so long to call for an ephedra ban in the first place. Part of the problem discussed is that the agency must show that a dietary supplement presents a “significant or unreasonable risk” to prevent it from being marketed. Therefore, ephedra was presumed to be safe when included in a dietary supplement. In contrast, for prescription drug formulas, the manufacturers must prove that a product is safe and effective before it can be marketed.

“Congress should immediately fund a systematic review of both the safety and the efficacy of all major dietary supplements. It should also give the FDA better tools to protect the public from unsafe or ineffective supplements,” the Center for Science in the Public Interest commented. In March of last year, Sen. Richard Durbin (D–IL) introduced a bill that would require manufacturers of stimulants in dietary supplements to prove that they are safe (S.B. 722). They would also be required to report and investigate any serious side effects of the supplements. S.B. 722 languished in a Senate Committee until recently, when new statements were heard from the bill’s sponsors.

At Brayton Purcell, we are committed to helping people who have been injured by unsafe medical drugs or dietary supplements. For more information about medical drugs, supplements, and your legal rights, please feel free to contact us. We have been handling medically–related litigation for over 20 years.