FDA warning over popular supplements
recall of two popular supplements - PC SPES, which is used for
prostate health, and SPES which is used to boost the immune system
- because they allegedly contain prescription drugs.
The US Food & Drug Administration (FDA) has issued a voluntary recall of two popular supplements - PC SPES, which is used for prostate health, and SPES which is used to boost the immune system - because they allegedly contain prescription drugs.
The FDA based its decision on a laboratory analysis conducted by the California Department of Health and Human Services (CDHHS) which found that PC SPES contained warfarin, a prescription blood thinner. The same analysis discovered traces of anti-anxiety drug alprazolam (also known as Xanax) in SPES. Both supplements are made by BotanicLab which has issued a voluntary recall of the products nationwide.
PC SPES contains eight herbs: baikal skullcap, Chinese liquorice, Dyer's woad, mum, rabdosia, reishi, san-qi ginseng and saw palmetto. The CDHHS analysis showed that one capsule of the supplement could contain as much as 0.211mg of warfarin, which means that an average consumption of six pills per day would give 1.27 mg of the blood thinner, approximately 63 per cent of the lowest dosage recommended by the Physician's Desk Reference (PDR).
While BotanicLab complied with the FDA ruling and withdrew the supplement, it has denied using warfarin, stating instead that what the CDHHS found may have been a phytocoumarin, a compound naturally synthesised in various green plants but which may appear like warfarin in laboratory tests.
As far as SPES is concerned, BotanicLab has confirmed through its own tests that the supplement did contain alprazolam, adding that the contamination was thought to have occurred with one of its suppliers. SPES contains a number of herbs such as broomrape, corydalis, Panax ginseng and pollen. The product is likely to be back on the market at the end of April, the company said.
The FDA said that consumers should immediately seek medical advice if they were taking either of the supplements, especially if they were taking other prescription medications.
Warfarin has been associated with serious cases of haemorrhaging and liver damage, while side effects associated with alprazolam include liver damage, dangerously low blood pressure and severe drowsiness.
