PC SPES, SPES (BotanicLab) Press Release, CA Dept of Health Services, Feb 2002
This is the retyped text of a Press Release from the California Department of Health Services. Contact the organization for a copy of any referenced enclosures.
NUMBER: 02-03 DATE: February 7, 2002
FOR RELEASE: IMMEDIATE
CONTACT: Ken August or Lea Brooks
STATE HEALTH DIRECTOR WARNS CONSUMERS ABOUT PRESCRIPTION DRUGS IN HERBAL PRODUCTS
SACRAMENTO - Consumers should immediately stop using the dietary supplement herbal products PC SPES and SPES capsules because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision, State Health Director Diana M. Bontá, R.N., Dr. P.H., said today. PC SPES and SPES are respectively marketed "for prostate health" and strengthening the immune system.
BotanicLab, the Brea-based manufacturer of the products, has voluntarily recalled PC SPES and SPES nationwide.
"Consumers should stop using these products and immediately seek medical advice, especially if they currently are using any other prescribed medication," Bontá said. "Consumers should consult with their health care providers whenever they take an herbal product or a dietary supplement."
Her warning followed an investigation and laboratory analysis of the products by the California Department of Health Services' Food and Drug Branch that found PC SPES contains warfarin and SPES contains alprazolam, which are available only by prescription and sold either by their generic names or the trade names, Coumadin and Xanax, respectively. Warfarin is an anticoagulant or "blood thinner" used to decrease the clotting ability of the blood, and alprazolam is used to treat anxiety and panic disorders.
Warfarin can cause serious bleeding, according to CDHS experts. This bleeding can be affected by many other different medicines, including aspirin and other anti-inflammatory or pain medicines, antibiotics and antifungals, thyroid drugs, antidepressants and cholesterol-lowering drugs.
Alprazolam exacerbates the effects of alcohol and other central nervous system depressants. It also may be habit forming.
PC SPES is available in 60-capsule bottles, and SPES is available in 30 capsule bottles, through mail or telephone order, Internet sales and from distributors, retailers and health care professionals.
PC SPES are clear capsules that contain light brown powder. The label is light brown with a blue border and the name "BotanicLab PC SPES" on the front panel. SPES are clear capsules that contain brown powder. The label is light brown with a brown border and the name "BotanicLab SPES" on the front panel.
Consumers who have unused SPES and PC SPECS capsules should return the product in its original packaging to PC SPES Recall Program 2900-B Saturn Street Brea, CA 92821 (1-800-458-5854). CDHS’ Food and Drug Branch is continuing to investigate these products and 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.
To view the recall notice, consumers may visit http://www.botaniclab.com/html/recall.html