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Urgent information: PC SPES recalled

You may have heard by now that PC SPES, the popular herbal prostate health formula, has been recalled. We thought it was important to address this issue as soon as possible and give you all the available information.

On Thursday, the California State Health Director issued a statement directing consumers to stop using PC SPES immediately, because the product may contain “undeclared prescription drug ingredients.” This announcement was followed by a voluntary recall of PC SPES by the product’s manufacturer, BotanicLab, while the product undergoes further testing.

According to the California Department of Health Services, random testing of PC SPES capsules found that they contained warfarin, a prescription blood thinner also known by the brand name Coumadin. Warfarin can interact with many other drugs, including over-the-counter analgesics like acetaminophen, aspirin, ibuprofen, and naproxen; heartburn medications like Tagamet and Zantac; and vitamin supplements containing vitamin K. The drug can also interact with antiobiotics, antifungals, thyroid drugs, antidepressants, and cholesterol-lowering drugs. The main side effect concern with warfarin is bleeding; problems could include nosebleeds, bleeding gums, and blood in the urine or stool.

According to BotanicLab, the standard maintenance dose of warfarin ranged between 2 to 10 milligrams per day. DHS testing found .211 milligrams of warfarin in one capsule of PC SPES; at the maximum recommended dosage of six capsules per day, a person could take in 1.27 milligrams of warfarin per day. That’s about 63 percent of the lowest dosage recommended by the Physician’s Desk Reference.

In response to the DHS’ findings, BotanicLab instituted a nationwide, voluntary recall of PC SPES. You can send any unused or opened packages of PC SPES to them and they will refund your money. For more information about the refund offer, visit BotanicLab’s website at www.botaniclab.com or call their recall hotline at 1-800-458-5854.

But here’s an interesting point that most mainstream media reports probably left out. Independent laboratory experts at BotanicLab believe that the DHS’ tests didn’t detect warfarin at all, but a phytochemical that mimics warfarin. They plan more precise testing to clear up the issue, plus more stringent quality control measures throughout their entire production process. A representative from BotanicLab couldn’t say when the company expects to get PC SPES back on the shelves – although they are confident that will happen.

In the meantime, remember that PC SPES has been used for many, many years by many people with good results. And although the lab results warrant further testing, BotanicLab says that they are not aware of any adverse PC SPES events related to this situation. If you take PC SPES, talk to your doctor about the potential risk. Here at HSI, we’ll keep you posted as new information becomes available.

Copyright 1997-2002 by Institute of Health Sciences, L.L.C.

 

 

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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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