Ephedra Use

by Food and Drug Administration (FDA)

The death of Baltimore Orioles pitcher Steve Bechler in February 2003 brought renewed attention to the dangers of using the herb ephedra. Bechler died from multiple organ failure due to heat stroke, and a dietary supplement containing ephedra was a contributing factor, according to Joshua Perper, M.D., chief medical examiner in Broward County, Fla.

Soon after Bechler's death at age 23, minor league baseball banned ephedra, joining other sports organizations that had already banned its use — the National Football League, the National Collegiate Athletic Association, and the International Olympic Committee.

Health officials recently cautioned American consumers against using ephedra-containing products, especially if strenuous exercise is involved, or in combination with other stimulants such as caffeine. Because ephedra is an adrenaline-like stimulant, it can have potentially dangerous effects on the nervous system and heart.

A naturally occurring substance derived from ma huang, a Chinese herbal medicine, ephedra has been promoted to help people lose weight, enhance athletic performance, and increase energy. Its principal active ingredient is a chemical called ephedrine.

Because ephedra is an herb, it is considered a dietary supplement regulated under the Dietary Supplement Health and Education Act of 1994. Under that law, the FDA does not review dietary supplements for safety and effectiveness before they are marketed. Rather, the law allows the FDA to prohibit sale of a dietary supplement only if it "presents a significant or unreasonable risk of injury."

Synthetic ephedrine, however, is regulated as a drug. Ephedrine-containing products taken orally can be sold over-the-counter (OTC) without premarket approval as long as they conform to the final monograph for OTC drug products used for temporary relief of asthma symptoms. Final monographs cover the formulation, use, and labeling of OTC drug products. Prescription medicines with ephedrine for uses other than those covered by the monograph require premarket review for safety and effectiveness.

Synthetic ephedrine can be found in OTC and prescription drugs taken orally for temporary relief of shortness of breath, chest tightness, and wheezing due to bronchial asthma. Synthetic ephedrine can also be used as a topical nasal decongestant (nose drops, sprays, or jelly) for temporary relief of nasal congestion due to colds, hay fever, sinusitis, or other upper respiratory allergies. As a regulated drug product, synthetic ephedrine has mandatory warnings and labeling for short-term use. It also isn't allowed to be used in combination with caffeine or other stimulants that could interact with it. The controlled availability of synthetic ephedrine drug products under FDA regulation has not been reported to be associated with the same level of severe adverse events that have been reported with dietary supplements containing ephedra.

Still, Barbara Michal, a paralegal in San Bernardino, Calif., says she's extremely concerned about the OTC availability of ma huang, ephedra, and ephedrine, whether in herbal form in dietary supplements or as synthetic ephedrine in drugs. She founded a nonprofit group called Halt Ephedrine Abuse Today (HEAT) after her son Kristopher died in 1997, at age 24, of sudden cardiac arrest due to an accidental ephedrine overdose.

"I got a frantic call from Kristopher's wife, Nicole, saying that he collapsed," says Michal. "All the paramedics could tell me was that he was down for 10 minutes and that they were working on him," she says. "I drove for three hours to get there — knowing without really knowing that my son was dead."

Michal says Kristopher was using one of two over-the-counter products containing synthetic ephedrine at different times: maximum strength Efedrin and Mini Two Way Action, formerly called Mini Thins. "The products are labeled as asthma aids, but I've known people who bought them from gas stations, truck stops, convenience stores and liquor stores, and used them as stimulants," Michal says. "Kristopher took them for a pick-me-up and, like many people, had no idea of the risks. For one thing, if he wasn't drinking Mountain Dew, he was drinking coffee. I have since learned that caffeine makes ephedrine even more dangerous." Both beverages contain caffeine.

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.