PC SPES Recalled for Alleged Drug Contamination 30318

PC SPES Recalled for Alleged Drug Contamination

BREA, Calif.--PC SPES, the popular prostatesupplement for prostate health, will be hard to find for the next few months.Today the Food and Drug Administration (FDA) reported that this and anothersupplement for immune health were voluntarily recalled for allegedly containingprescription drugs. A laboratory analysis conducted by the California Departmentof Health and Human Services (CDHHS) (www.dhs.ca.gov) found PC SPES to containwarfarin, a prescription blood thinner, and SPES, an immune-enhancing supplementthat contained alprazolam (better known as Xanax). The manufacturer, Brea,Calif.-based BotanicLab (www.botaniclab.com), has issued a voluntarily recall ofthe products nationwide.

PC SPES, which was introduced in 1996, contains eight herbs: baikal skullcap,Chinese licorice, Dyer's woad, mum, rabdosia, reishi, san-qi ginseng and sawpalmetto. A 60-count bottle offers a 10-day supply of product. CDHHS reportedthat the highest finding of warfarin (brand name Coumadin) it found in a PC SPEScapsule was .211 mg. In a dose of six pills per day, the amount of warfarin isplaced at 1.27 mg/d, which is approximately 63 percent of the lowest dosagerecommended by the Physician's Desk Reference (PDR).

However, BotanicLab contends that the material CDHHS found may have been aphytocoumarin, a compound naturally synthesized in various green plants that mayappear like warfarin in laboratory tests. The company has conducted its ownindependent tests of PC SPES and reported that "based on the advice of[our] experts, further analysis and testing is needed before a finaldetermination can be made. ... Second, we are also undertaking additionaltesting of PC SPES ... to settle the question of whether the material at issueis synthetic or natural."

When the news broke, BotanicLab received numerous calls from customersconcerned about this news. "We're looking out for the best interest of ourcustomers," stated John Sonego, a spokesperson for the company. "Evenif we don't believe [CDHHS's] test results were not completely accurate, we justwant to take that precaution. We're continuing to work with them since they'relooking at the results of our [outside] testing." He added that he did notknow which herb may have caused the drug-positive results, especially sincephytocoumadin is a natural compound found in more than 300 green plants.

Sonego did say that when doing its own tests on its SPES immuneproduct--which contains such herbs as broomrape, corydalis, Panax ginseng andpollen--BotanicLab also found it to be contaminated with alprazolam. "Webelieve that the contamination occurred with one of our suppliers," hesaid, adding that while the product is recalled, the company will be correctingthe problem. "We're anticipating shipping that product again after April30."

In the meantime, the company has also sent a letter dated Feb. 8 to its PCSPES customers discussing the recall. BotanicLab apologized for the productshortage this has caused, and the company explained that it is conductingadditional tests and implementing a new quality control process for its PC SPESproducts.

This is not the first time PC SPES has been in the news. The Oct. 18 issue ofthe New England Journal of Medicine (345:1213-4, 2001)reported PC SPES was the suspected cause of severe internal bleeding in one man.According to the NEJM letter (www.nejm.org), a Seattle mansuffered severe internal bleeding after taking 12 capsules of PC SPES daily fora month, which is twice the recommended dosage. At around the same time thiscase study was released, two batches of PC SPES products tested positive forcontaining diethylstilbestrol (DES), a synthetic form of estrogen that mayincrease the risk of uterine cancer in children whose mothers took the compound.Susan Domizi, wife of a prostate cancer survivor who took PC SPES for years,initiated the testing of the PC SPES products. Even though BotanicLab stated atthe time that DES has never been an ingredient in PC SPES, the company decidedto err on the side of caution and issued a request that consumers in possessionof unopened bottles of PC SPES (lot numbers 5,430,125 and 5,438,285) send thesamples back for further testing. No samples were returned during the four-weekdeadline and, as further support, the test conducted by FDA also found no DES.

Despite the issues this supplement has faced, this natural therapy forprostate health has been very promising. In one recent study, 23 patients withandrogen-independent prostate cancer were treated with three capsules of PC SPESdaily (Urology, 57, 1:122-6, 2001). A follow-up eight monthslater showed that 20 patients experienced a median post-therapy decline of 40percent in prostate-specific antigen (PSA), prostate cancer marker. In addition,researchers from the University of California, Los Angeles, found that a PC SPEScomponent, baicalin, may inhibit the proliferation of cancer cells(Prostate, 49, 4:285-92, 2001). Baicalin is a flavonoidnon-nucleoside reverse transcriptase inhibitor (NNRTI) isolated from thetraditional Chinese medicinal plant Scutellaria Baicalensis Georgi,or baikal skullcap. [Editor's Note: Both of these studies can be found on PubMedat www.ncbi.nlm.nih.gov.]

Until this matter is sorted out, the company stands behind its products."We really believe in the value of these products," Sonego stated."We hope to correct all of the deficiencies in our manufacturing process,from the suppliers to the manufacturer."

Sonego went on to say that by the time the company brings PC SPES back to themarket--hopefully within a few months--it will have measures in place to makesure its ingredients are free from contaminants.