California Health Authorities Warn Consumers about Prescription Drugs in Herbal Products

On February 7, 2002, California health authorities warned consumers to stop immediately the use of two dietary supplement drug products, PC SPES and SPES, because they contain prescription drugs not listed on their labels that could cause serious health problems. These unregulated drug supplements are produced by BotanicLab of Brea, California.

A laboratory analysis of these products done by the California Department of Health Services’ Food and Drug Branch found that PC SPES contains warfarin and SPES contains alprazolam. Warfarin (COUMADIN) is an anticoagulant (blood thinner) that can lead to uncontrolled bleeding if its use is not monitored by a physician. Alprazolam (XANAX) is one of a family of drugs known as benzodiazepines that includes diazepam (VALIUM) as its best-known member. All benzodiazepines cause drowsiness and even short term use can lead to dependence.

According to BotanicLab, “PC” stands for prostate care and “SPES” is the Latin word for hope. Another word for selling hope in the form of a drug of unproven safety or effectiveness is quackery. The drug, sold for “prostate health,” is purported to contain chrysanthemum, dyer’s woad, licorice, reishi, san-qi ginseng, rabdosia, baikal skullcap and saw palmetto. The saw palmetto comes from domestic sources, while the rest are Chinese herbs.

SPES is a bewildering array of 15 herbs. The producer proclaims “SPES helps support the body after long term weakness. Only herbal extracts which pass our rigid standards are used. SPES does not contain any artificial ingredients.” We wonder how the alprazolam got past the “rigid standards.”

Consumers who have SPES and PC SPES capsules should return them to PC SPES Recall Program, 2900-B Saturn Street, Brea CA 92821 (1-800-458-5854) and demand a refund. The California Department of Health Services’ Food and Drug Branch, which is continuing to investigate these products, can be reached at 1-800-495-3232 for more information. The U.S. Food and Drug Administration is assisting in the investigation and monitoring of the recalls throughout the United States.

The Pure Food and Drug Act of 1906 was written, in part, to assure consumers of the identity of the articles they purchased by requiring disclosure on the label of what is in the bottle. Now, 96 years later, American consumers face the same unregulated marketplace for dietary supplement drugs that may contain unknown ingredients because of the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 that for all practical purposes deregulated the production and sale of dietary supplements. The responsibility of the present state of affairs can be laid squarely at the feet of Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), the primary proponents of DSHEA.

Even doctors and pharmacists, as well as the general public, are in the dark about the quality or purity of dietary supplement drugs now flooding the marketplace. Purchasing these products over the Internet or from the local health food store, an independent pharmacy, a national chain, or your own physician is no guarantee that you will be buying what the labels say is in these concoctions.

What You Can Do

You should avoid the use of dietary supplement drugs except for some vitamins and minerals such as calcium. These unregulated drugs carry the possibility of substantial risk without any proof of benefit.