ROCKVILLE, Md., Jan. 21 /PRNewswire/ -- The Food and Drug Administration
is alerting consumers not to purchase or consume products, some of which are
labeled as dietary supplements, that contain gamma butyrolactone (abbreviated
as GBL). FDA has also asked the companies that manufacture these products to
voluntarily recall them. The agency has received reports of serious health
problems -- some that are potentially life-threatening -- associated with the
use of these products.
Although labeled as dietary supplements, these products are illegally
marketed unapproved new drugs. Products containing GBL are marketed under
various brand names including Renewtrient, Revivarant or Revivarant G, Blue
Nitro or Blue Nitro Vitality, GH Revitalizer, Gamma G, and Remforce. They
are promoted with claims to build muscles, improve physical performance,
enhance sex, reduce stress and induce sleep.
GBL is also known by the chemical names 2(3H)-furanone dihydro;
butyrolactone; gamma-butyrolactone; 4-butyrolactone; dihydro-2(3H)-furanone;
4-butanolide; 2(3H)-furanone, dihydro; tetrahydro-2-furanone; and
butyrolactone gamma.
GBL related products have been associated with reports of at least 55
adverse health effects, including one death. In 19 of those cases, the
consumers became unconscious or comatose and several required intubation for
assisted breathing. Other reported effects included seizures, vomiting, slow
breathing, and slow heart rate. There are reports of at least 5 children
under 18 years of age who have been injured or who have suffered these kinds
of effects.
When taken orally, GBL is converted in the body to gamma hydroxybutyrate
or GHB. GHB is a very potent unapproved drug. It is currently being
investigated under the supervision of doctors for the treatment of narcolepsy.
Because of its serious side effects, GHB should not be taken unless in the
context of these FDA approved investigations. FDA and the Justice Department
have ongoing criminal enforcement actions against GHB. GBL should not be
taken.
Products containing GBL are sold in liquid and powder form. They are sold
via the Internet, in some health food stores, and in some gymnasiums and
fitness centers.
Consumers are advised to dispose of any products of this type in their
possession. If they have experienced adverse health problems from use of
these products, they should promptly contact a physician. FDA requests
consumers and physicians to report adverse events to FDA's MEDWATCH
1-800-332- 1088.
The Trimfast Group, Inc. has agreed to recall the product Revivarant, 32
ounces of liquid in a plastic bottle, and Revivarant G, 200 grams of powder in
a pill bottle. Other companies manufacturing products containing GBL are
being asked by the FDA to voluntarily recall them.
FDA is considering all potential regulatory actions at its disposal if
products containing GBL are not recalled. The agency will act expeditiously
to protect the public health.
SOURCE Food and Drug Administration
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