CSPI Asks FDA for Black Cohosh Warning

WASHINGTON--In a March 8 media advisory, the Center for Science in the Public Interest (CSPI) asked the Food and Drug Administration (FDA) to warn women and the medical community that black cohosh may increase the risk of breast cancer spreading to the lungs and liver toxicity. CSPI also called on the National Institutes of Health--which is currently studying the effectiveness of black cohosh in relieving hot flashes and other symptoms of menopause--to advise study subjects of these and other possible adverse events.

CSPIs recommendations stem from a July 2003 study presented at the 94th Annual Meeting of the American Association for Cancer Research that indicated rats given black cohosh had a likelier chance of having cancer spread from the breast to the lungs. (For more on the story, visit www.naturalproductsinsider.com/hotnews/37h14104728.html?wts=20040312023651&hc=249&req=black+and+cohosh.)

CSPI also reported at least three cases in medical literature have linked liver toxicity in women to herbal remedies containing black cohosh. This led CSPI senior nutritionist David Schardt to recommend, Women, particularly women who have had breast cancer, should think twice before taking black cohosh.

In a letter to FDA Commissioner Mark McClellan, CSPI said FDA should also notify physicians about the potential risks of black cohosh, and to urge them to submit any data on liver toxicity or cancer metastasis from patients taking black cohosh.

According to CSPI, concerns over hormone replacement therapy (HRT) were renewed last week when another government-sponsored study was halted for safety reasons. CSPI believes supplement manufacturers may again be eager to exploit those concerns and aggressively market black cohosh as a substitute.

However, not just the supplement industry supports natural alternatives to HRT. In the January/February issue of its Menopause (11, 1:11-33, 2004) (www.menopause.org/journals/m/menopause.html), the National American Menopause Society (NAMS) recommended nonprescription remedies such as dietary isoflavones, black cohosh and vitamin E to help relieve mild hot flashes rather than conventional HRT. NAMS reported no serious side effects have been associated with long-term administration of soyfoods and isoflavone supplements, black cohosh or vitamin E.

And in 2001, the American College of Obstetricians and Gynecologists stated--primarily on the basis of consensus and expert opinion--black cohosh may be helpful in the short term (six months or less) for women with vasomotor symptoms of menopause (ACOG Practice Bulletin, 28: 1-11, 2001.)

And in October 2003, the National Center for Complementary and Alternative Medicine (NCCAM) released "Questions and Answers About Black Cohosh and the Symptoms of Menopause." The report (http://ods.od.nih.gov/factsheets/blackcohosh.html) discusses common preparations, historical uses and drug interactions associated with this herb. NCCAM included a cautionary statement within the report: Women with breast cancer may want to avoid black cohosh until its effects on breast tissue are understood.

For more on the CSPI actions, visit www.cspinet.org/new/200403081.html.