Two Contaminated Herbal Supplements Recalled

Amid growing concern about the lack of regulation over herbal supplements, the FDA announced on Friday that it was launching an investigation of a California supplement manufacturer following the voluntary recall of two of its products that were discovered to be contaminated with "potentially harmful" prescription drugs, the Los Angeles Times reports. BotanicLab Inc. urged consumers on Friday to immediately stop taking PC SPES, a "promising" therapy for prostate cancer, and SPES, an immune system supplement, after California health officials determined that both products were contaminated. The state Department of Health Services announced that its investigators had found the blood-thinning drug Coumadin, known generically as warfarin, in PC SPES and the anxiety drug Xanax, known generically as alprazolam, in SPES. Both are prescription drugs and are only supposed to be taken on the advice of a doctor.

These findings led FDA officials to warn consumers that the supplements may pose serious health risks. "In this case, the agency's warning is due to the finding of the California state government that the ingredients in (the supplements) posed serious health risks," FDA spokesperson Jason Brodsky said, adding, "We certainly are supportive of the company's decision to recall the products" (Herndon, Los Angeles Times, 2/8). Warfarin can cause "serious bleeding, especially if taken together with aspirin or certain other drugs," while alprazolam "exacerbates the effects of alcohol and other sedating drugs and may be habit forming" (AP/Washington Post, 2/9). The recalls come as medical experts nationwide increasingly express concern over supplement regulation, the Times reports. Because they are classified as food supplements, herbal supplements, unlike prescription drugs, are not subject to FDA regulation -- the result of a 1994 law that shifted oversight of product safety and labelling accuracy away from the agency and toward manufacturers themselves.

The recall of PC SPES marks a setback for one of the "few herbal supplements to demonstrate substantial therapeutic effects," the Times reports. A clinical trial of the supplement, which is taken by at least 10,000 American men, had been underway at the University of California-San Francisco, and initial data suggested that 45% of participants who took PC SPECS have shown at least a 50% reduction in their "prostate-specific antigen levels, considered a marker for prostate cancer." But the study was "abruptly halted" recently after researchers at the university, who independently confirmed their findings with the Times, tested four lots of PC SPES and discovered that all contained "yet a third contaminant," diethylstilbestrol, or DES, a "hormone that was once used to prevent miscarriages but later was banned when it was shown to cause birth defects in children and blood clots and other side effects among men" (Los Angeles Times, 2/9).

However, in its product recall statement posted on its Web site today, BotanicLab strongly denied that DES is present in PC SPES, saying that four rounds of testing since 1998 have shown no contamination. The company said it believed that the contamination of SPES with alprazolam may have occurred in China with its raw material suppliers, adding that it has "imposed more rigorous controls in our supply chain review process as well as expanded [its] product testing to ensure such contamination does not occur again." BotanicLab added that it believes more testing and analysis is needed to determine conclusively whether warfarin is in PC SPES, but said it believes its "first responsibility is to the safety and well being of [its] customers" (BotanicLab release, 2/11). California officials initiated the testing of the supplements after a Southern California district attorney reported receiving numerous complaints about adverse effects from PC SPES (Los Angeles Times, 2/9).