Supplement Fouls Out With FDA

Marketed under such names as Blue Nitro, Firewater and Invigorate, a dietary sports supplement popular with fitness buffs and athletes promises to help muscles recover faster and aid in sleeping after an intense workout.

But the supplement is being blamed for the near-fatal seizure suffered by Phoenix Suns forward Tom Gugliotta recently after the athlete took some at a friend’s suggestion.

The supplement remains popular despite reports of at least six deaths and numerous safety warnings from the U.S. Food and Drug Administration. The agency considers it an unapproved drug and, therefore, illegal to manufacture and distribute for human consumption.

Gugliotta suffered a seizure aboard the Suns’ team bus after a game in Portland on Dec. 17 and was hospitalized in serious condition. Team doctor Richard Emerson said a supplement containing gamma butyrolactone, or GBL, most likely caused the seizure. Gugliotta has said he took the supplement twice because of trouble sleeping; the first time he had no problems with it.

GBL is available as a liquid or powder at gyms and fitness centers, through the Internet, and in some health-food stores under many different brand names, such as Renewtrient, Revivarant, Blue Nitro Vitality, Insom-X and GH Revitalizer. In addition to fitness uses, it’s also marketed for weight loss and stress reduction.

The FDA has issued public warnings that GBL can cause “dangerously low respiratory rates,” requiring a doctor to insert a breathing tube into the patient’s throat, as well as unconsciousness, coma, vomiting, seizures and death.

As an industrial product, the chemical is a solvent used as a paint stripper that can easily be found in hardware stores, said Laura Bradbard, an FDA spokeswoman.

She said several states have made it illegal to possess the chemical for human consumption. At the federal level, she said, there are actions afoot to make it a Schedule I substance, like heroin, that is illegal to possess.

As of Dec. 16, the day before Gugliotta’s seizure, the FDA had tallied 116 arrests, 55 convictions, and 38 GBL-related indictments handled by the agency’s Office of Criminal Investigations.

As of Dec. 9, the FDA had received reports from medical professionals and hospitals of 242 incidents, including six deaths and 191 cases in which medical intervention was required. The remaining reports were not confirmed as caused by GBL or related chemicals, Bradbard said.

Because reporting is voluntary, “we’re only getting a small portion of what is probably going on,” Bradbard said. Reports are coming to the agency from every part of the country and from several groups of users--”sometimes young partyers, sometimes just people who want to lose a few pounds.”

The body breaks GBL down into gamma hydroxybutyric acid, or GHB, a so-called date-rape drug that is colorless, tasteless and can be added to alcohol to produce an unconscious state. Researchers are also studying GHB in FDA-approved trials for treating narcolepsy, a neurological disorder that causes chronic daytime sleepiness.

In 1990, the FDA banned the use of GHB and warned consumers to stop using it because of health risks. Authorities believe some companies then began producing GBL instead. After the FDA warned about that substance, companies began making BD, which stands for 1,4 butadeniol, a chemically similar compound sold as a sleep aid, party drug and muscle builder.

GBL products also may be labeled as containing 2(3H)-furanone dihydro, butyrolactone, gamma-butyrolactone, 4-butyrolactone, dihyro-2(3H)-furanone, 4-butanolide and tetrahydro-2-furanone.

There is no research to demonstrate the safety or effectiveness of most of the GBL-like compounds, Bradbard said. Of the manufacturers, she said: “These are opportunists.”

The FDA and the Justice Department are trying to make criminal cases against companies that manufacture or market GBL for human use.

Bradbard said the FDA has staffers looking at Internet sites for distributors of the drug, but she said sites come and go .

“If someone is mixing these chemicals together and giving them to people, marketing them and distributing them, then we can go through regulatory procedures,” Bradbard said. “There’s only so much authority that the FDA has. Aside from the Internet, you can simply go to your gym and somebody can offer you something. It’s very hard to track down.”

Bradbard said she didn’t know whether the agency had begun looking into which company manufactured the supplement that Gugliotta consumed. Phoenix Suns officials have declined to name the product.

“Any time we learn of an adverse event or sale of these products, we investigate,” she said.

Part of President Clinton’s new initiative to protect consumers from illegal pharmaceutical sales on the Internet includes a proposal to upgrade the FDA’s computer technology to identify, investigate and prosecute Web sites that sell unapproved drugs.