U. S. Food and Drug Administration
Medwatch
August 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.

This is a mirror of the page at http://www.fda.gov:80/medwatch/SAFETY/1999/gblghb.htm

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