Supplements Can Be Fatal, FDA Says

WASHINGTON — Three people have died and dozens more have been seriously injured by a chemical contained in dietary supplement products sold as sleep aids, the Food and Drug Administration said Tuesday.

The FDA said it had confirmed the three deaths, and officials are investigating additional reports of fatalities. Authorities are also investigating reports that 119 people have suffered serious adverse reactions, including becoming unconscious or comatose or requiring the insertion of a breathing tube, after ingesting the chemicals.

The deaths were caused by a substance known as BD (1,4 butanediol), which is the latest chemical discovered to cause problems. It is one of a family of chemicals, including GBL (gamma butyrolactone) and GHB (gamma hydroxzybutyric acid), which in various forms have been sold as muscle builders and aphrodisiacs. None can be legally sold as drugs in the United States.

Nevertheless, FDA officials believe that some companies are still putting them in their products, particularly BD, and marketing them as sleep aids. BD is also sold as an industrial solvent.

“I would use extreme caution, and if there is any doubt, the safest route is to consult your doctor or pharmacist,” said Dr. Janet Woodcock, director of the FDA’s center for drug evaluation and research. “People may be buying these products thinking they are harmless natural remedies, but they’re buying paint thinner.”

The products are listed as “party drugs” on Internet sites and advertised in muscle-building magazines, the FDA said.

“All are illegal, but companies are making them, and if they are not voluntarily withdrawn from the shelves, we will seize them,” Woodcock said. However, “we have to find all of them, and they are all under different names.”

Nutritional supplements are largely unregulated by the federal government, so consumers “may be unnecessarily exposing themselves to serious harm,” the FDA said in a statement.

The agency warned consumers against taking any products containing BD, which are sold under such names as Revitalize Plus, Serenity, Enliven, GHRE, SomatoPro, NRG3, Thunder Nectar and Weight Belt Cleaner.

The chemical can cause dangerously low respiratory rates, unconsciousness, vomiting, seizures and death, the FDA said. It may increase the effects of alcohol, and is even more hazardous when taken with other depressant drugs, the agency said.

GHB is being studied by some researchers as a treatment for narcolepsy, an ailment in which people suffer uncontrollable episodes of sleep. Although other uses of GHB are illegal, the FDA believes that some laboratories have been illegally producing the chemical for use as a “date rape” drug.

These chemicals were the ones that sickened more than 100 New Year’s Eve partygoers in Los Angeles two years ago who drank “Cherry fX Bombs,” “Lemon fX drops” and “Orange fX Rush,” all contaminated with BD, the FDA said.

The FDA warned that many supplement labels do not list these substances. In other cases, BD may be listed as 1,4 butanediol or tetramethylene glycol, and GBL may be listed as gamma butyrolactone or 2(3H)-Furanone di-hydro, the agency said.