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Jan. 5, 2000 (Atlanta) -- When Phoenix Suns forward Tom Gugliotta recently suffered a seizure that caused him to miss seven games, team doctors suspected the culprit was a supplement he took for insomnia called gamma butyrolactone (GBL). The attack nearly killed him, and the FDA says he's one of the lucky ones. The agency has been working for months to try to get the product, which has been linked to three deaths, off the market. But some athletes continue to use it.
In addition to the deaths, more than 100 serious illnesses are attributed to GBL, according to a warning issued by the FDA last summer. Although available at health food stores and fitness centers as a dietary supplement, the FDA classifies it as an unapproved new drug not legal for sale in the U.S. and has requested a voluntary recall from manufacturers.
GBL is closely related to gamma-hydroxybutyrate (GHB), which was banned by the FDA in 1990. Since then, marketers have substituted GBL for GHB. These compounds, used to make floor stripper and paint thinner, can cause breathing problems, vomiting, seizures, coma, and death.
"Any product that will put you to sleep is a drug," says FDA spokeswoman Laura Bradbard. "And the only assurance of a drug's safety and effectiveness is FDA approval."
Bradbard tells WebMD that GBL is a potent central nervous system depressant with a narrow index between survival and death. "What makes GBL so dangerous is that people react differently to the same amount. Some survive and others don't. And this is particularly true when taken with other drugs or alcohol." Bradbard says GHB sales were virtually eliminated in 1991.
The FDA says GBL-related products are also promoted to athletes as an alternative to steroids for bodybuilding. Additionally, GBL is listed on the Internet as a "party drug" and has been implicated in date rape.
Brand names of dietary supplements containing GBL include Blue Nitro, Firewater, Gamma G, G.H. Revitalizer, Insom-X, Invigorate, Longevity, Remforce, and Revivarant. Brands promoted for party use include Cherry fX Bombs, Lemon fX Drops, and Orange fX Rush.
"The FDA and Department of Justice took action against several manufacturers and importers. But now GBL is manufactured in clandestine laboratories and their distributors claim it's legal." Bradbard says the FDA's Office of Criminal Investigations is working with local officials to arrest, indict, and convict those responsible.
In a letter to one marketer requesting an immediate recall, the FDA says that the product "does not meet the definition of a dietary supplement" and "does not bear adequate directions for use." The letter also states that products containing GBL are drugs and that marketing drugs without FDA approval is prohibited. Experts say athletes often learn about supplements from their trainers.
"Athletes rarely even inquire about dietary supplements," says John Xerogeanes, MD, the chief of sports medicine and assistant professor of orthopedic surgery at Emory University. "They're often endorsed by trainers and sold at the gym." Xerogeanes says, "Doctors don't know which brands have harmful ingredients because they're not profiled in medical journals. But Tom Gugliotta's experience has certainly raised awareness about GBL."
But the FDA says awareness may not be enough to minimize recreational use. Bradbard tells WebMD, "It's possible that possession will become a criminal offense."