PC SPES Recalled for Alleged Drug Contamination

BREA, Calif.--PC SPES, the popular prostate supplement for prostate health, will be hard to find for the next few months. Today the Food and Drug Administration (FDA) reported that this and another supplement for immune health were voluntarily recalled for allegedly containing prescription drugs. A laboratory analysis conducted by the California Department of Health and Human Services (CDHHS) (www.dhs.ca.gov) found PC SPES to contain warfarin, a prescription blood thinner, and SPES, an immune-enhancing supplement that contained alprazolam (better known as Xanax). The manufacturer, Brea, Calif.-based BotanicLab (www.botaniclab), has issued a voluntarily recall of the 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 saw palmetto. A 60-count bottle offers a 10-day supply of product. CDHHS reported that the highest finding of warfarin (brand name Coumadin) it found in a PC SPES capsule was .211 mg. In a dose of six pills per day, the amount of warfarin is placed at 1.27 mg/d, which is approximately 63 percent of the lowest dosage recommended by the Physician's Desk Reference (PDR).

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

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

Sonego did say that when doing its own tests on its SPES immune product--which contains such herbs as broomrape, corydalis, Panax ginseng and pollen--BotanicLab also found it to be contaminated with alprazolam. "We believe that the contamination occurred with one of our suppliers," he said, adding that while the product is recalled, the company will be correcting the problem. "We're anticipating shipping that product again after April 30."

In the meantime, the company has also sent a letter dated Feb. 8 to its PC SPES customers discussing the recall. BotanicLab apologized for the product shortage this has caused, and the company explained that it is conducting additional tests and implementing a new quality control process for its PC SPES products.

This is not the first time PC SPES has been in the news. In the Oct. 18 issue of the 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 man suffered severe internal bleeding after taking 12 capsules of PC-SPES daily for a month, which is twice the recommended dosage. At around the same time this case study was released, two batches of PC SPES products tested positive for containing diethylstilbestrol (DES), a synthetic form of estrogen that may increase 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 at the time that DES has never been an ingredient in PC SPES, the company decided to err on the side of caution and issued a request that consumers in possession of unopened bottles of PC SPES (lot numbers 5,430,125 and 5,438,285) send the samples back for further testing. No samples were returned during the four-week deadline and, as further support, the test conducted by FDA also found no DES.

Despite the issues this supplement has faced, this natural therapy for prostate health has been very promising. In one recent study, 23 patients with androgen-independent prostate cancer were treated with three capsules of PC SPES daily (Urology, 57, 1:122-6, 2001). A follow-up eight months later showed that 20 patients experienced a median post-therapy decline of 40 percent in prostate-specific antigen (PSA), prostate cancer marker. In addition, researchers from the University of California, Los Angeles, found that a PC SPES component, baicalin, may inhibit the proliferation of cancer cells (Prostate, 49, 4:285-92, 2001). Baicalin is a flavonoid non-nucleoside reverse transcriptase inhibitor (NNRTI) isolated from the traditional Chinese medicinal plant Scutellaria Baicalensis Georgi, or baikal skullcap. [Editor's Note: Both of these studies can be found on PubMed at 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 the market--hopefully within a few months--it will have measures in place to make sure its ingredients are free from contaminants.