CSPI Asks FDA for Black Cohosh Warning 28173

CSPI Asks FDA for Black Cohosh Warning

WASHINGTONIn a March 8 mediaadvisory, the Center for Science in the Public Interest (CSPI) asked the Foodand Drug Administration (FDA) to warn women and the medical community that blackcohosh may increase the risk of breast cancer spreading to the lungs and livertoxicity. CSPI also called on the National Institutes of Healthwhichis currently studying the effectiveness of black cohosh in relieving hot flashesand other symptoms of menopauseto advise study subjects of these and otherpossible adverse events.

CSPIs recommendations stem from a July 2003 study presentedat the 94th Annual Meeting of the American Association for Cancer Research thatindicated rats given black cohosh had a likelier chance of having cancer spreadfrom the breast to the lungs.

CSPI also reported at least three cases in medical literaturehave 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 takingblack cohosh.

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

According to CSPI, concerns over hormone replacement therapy(HRT) were renewed the week of March 1 when another governmentsponsored studywas halted for safety reasons. CSPI believes supplement manufacturers mayagain be eager to exploit those concerns and aggressively market black cohosh asa substitute.

However, not only the supplement industry supports naturalalternatives to HRT. In the January/February issue of Menopause (11,1:11- 33, 2004) (www.menopause.org/journals/m/menopause.html), the NationalAmerican Menopause Society (NAMS) recommended nonprescription remedies such asdietary isoflavones, black cohosh and vitamin E to help relieve mild hot flashesrather than conventional HRT. NAMS reported no serious side effects have been associatedwith longterm administration of soyfoods and isoflavone supplements, blackcohosh or vitamin E.

And in 2001, the American College of Obstetricians andGynecologists statedprimarily on the basis of consensus and expert opinionblackcohosh may be helpful in the short term (six months or less) for women withvasomotor symptoms of menopause (ACOG Practice Bulletin, 28: 1-11, 2001).

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

For more on the CSPI actions, visit www.cspinet.org.