FDA CITES DANGER IN WIDELY SOLD DRUG

One death, other severe reactions blamed on product

WASHINGTON, D.C. -- Americans should not consume a chemical widely
sold in health food stores and over the Internet that has been linked
to one death and 54 cases of severe reactions including seizures and
comatose-like states, the government warned Thursday.

The chemical -- sold in the guise of a dietary supplement and under
half a dozen names including GBL and Blue Nitro -- claims to have such
effects as building muscle, enhancing sexual performance and reducing
stress.

Instead, GBL can act on the central nervous system to cause
life-threatening reactions, the Food and Drug Administration said.

"We really want to get out a clear warning to consumers that this is a
dangerous product, and they should not be using it," said Joe Levitt,
FDA's director of food safety.

The FDA has learned of 55 people who suffered reactions, including a
woman found dead in her home after ingesting GBL. Nineteen other
people lost consciousness, many with such difficulty in breathing that
they required insertion of breathing tubes. Several GBL users were
found incoherent while driving, and one was involved in a car crash.
Others appeared to have suffered seizures.

Many were young adults, but four patients were teen-agers and a fifth
was an 11-year-old. The FDA provided no further details.

The FDA is tracking down at least six companies that sell GBL under
the guise of a dietary supplement. The government says GBL, or gamma
butyrolactone, is not a dietary supplement but is a derivative of a
powerful party drug banned in the United States since 1991.

When people ingest GBL, it breaks down into the drug known as GHB, or
gamma hydroxybutyrate. GBH is a potent drug that some scientists are
studying in carefully monitored clinical trials as a potential
treatment for narcolepsy, but all other uses of GHB are illegal.
Despite that ban, the FDA two years ago discovered laboratories
illegally producing the odorless, tasteless chemical as a party drug.
It was blamed for dozens of hospitalizations and at least three
deaths during a brief resurgence, and it became known as a "date rape"
drug after rendering women helpless when it was slipped into their
drinks.

The agency is asking manufacturers to recall all GBL products, and one
company, Florida-based Trimfast Group Inc., has agreed. It is
recalling GBL sold under the names Revivarant, sold as a liquid in
32-ounce bottles, and Revivarant G, sold as a powder to be mixed in
drinks.

In addition to the recalled Revivarant, the FDA said GBL is sold by
companies in Florida and California under the brand names Blue Nitro
or Blue Nitro Vitality, GH Revitalizer or GHR, Remforce, Renewtrient
and Gamma G.