| U.S. Food and Drug Administration |
Medwatch, Aug 25, 1999
IMPORTANT MESSAGE FOR HEALTH PROFESSIONALS
Report Serious Adverse Events Associated with Dietary Supplements Containing
GBL, GHB, or BD
FDA has been warning the public about a group of products sold as dietary
supplements for bodybuilding, weight loss and sleep inducement which have been
determined to pose a significant public health hazard. These products are
chemically related to gamma butyrolactone (GBL), gamma hydroxybutyric acid
(GHB), and 1,4 butanediol (BD), and can cause dangerously low respiratory rates
(intubation may be required), unconsciousness/coma, vomiting, seizures,
bradycardia and death.
GBL, GHB and BD have been linked to at least 122 serious illnesses reported
to FDA, including three deaths. These agents, which are powerful hypnotic
substances known to produce significant and potentially dangerous sedative
effects, also increase the effects of alcohol and are even more dangerous when
consumed with other central nervous system depressant drugs.
While these products are listed as "party drugs" on internet sites,
advertised in muscle-building magazines, and sold in health food stores as
dietary supplements, the FDA considers them to be unapproved new drugs and has
conducted seizures to prevent their sale to consumers and any further illnesses
or deaths. GHB, which is legally available in the United States only as an
investigational new drug for specified purposes (thus, it cannot be legally
marketed), has been implicated as a "date rape" drug.
Regarding the products themselves:
- GBL, when ingested, rapidly metabolizes into GHB.
- Some of the suspect products may list 1,4 butanediol, tetramethylene
glycol, gamma butyrolactone or 2(3H)-Furanone di-hydro on the label, or have
no label at all.
- Health authorities believe manufacturers are renaming their products and
substituting BD for GBL - however, the effects of ingesting BD are as
dangerous as those of GHB and GBL.
- GBL product names include Longevity, Revivarant, G.H. Revitalizer, Gamma
G, Blue Nitro, Insom-X, Remforce, Firewater and Invigorate.
- Products that contain BD include Revitalize Plus, Serenity, Enliven, GHRE,
SomatoPro, NRG3, Thunder Nectar and Weight Belt Cleaner.
- Consumers have been warned by FDA not to drink the products named Cherry
fX Bombs, Lemon fX Drops and Orange fX Rush, as all contain BD.
FDA can not ensure the effectiveness or safety of any product for sleep
inducement other than FDA approved drugs. People who use unapproved sleep
inducement products, especially without proper medical supervision, may be
unnecessarily exposing themselves to serious harm.
FDA strongly encourages you to report any serious adverse events that occur
with the use of any dietary supplement containing GBL, GHB or BD to the FDA's
MedWatch program by:
- Phone (1-800-FDA-1088)
- Fax (1-800-FDA-0178)
- Via the MedWatch website at www.fda.gov/medwatch
- Mail (using postage-paid form) to MedWatch, HF-2, 5600 Fishers Lane,
Rockville, MD 20852-9787.
By reporting to MedWatch, you can contribute to the public health by helping
to prevent further illnesses or deaths associated with these products.
The text in this article was prepared by the FDA Office of Public Affairs.