PRACTICE RESOURCES > Regulation/AUA Positions, Letters, and Talking Points > FDA Regarding Food Supplements Containing Saw Palmetto


FDA Regarding Food Supplements Containing Saw Palmetto

May 2000

Statement to the United States Food and Drug Administration

The American Urological Association (AUA) representing 9,500 urologists in the United States appreciates the opportunity to present its views on the issues of food supplements containing saw palmetto. The AUA wishes to emphasize, once again, in the strongest possible terms that lower urinary tract symptoms in older men (urinary frequency, urinary urgency, slowing of the urinary stream, hesitation on initiation of urination and rising at night to void multiple times) are often due to diseases of the genitourinary system. They are usually NOT a normal phenomenon of aging. The AUA is deeply concerned that food supplements containing saw palmetto currently being offered to maintain prostate health, to treat benign prostatic hyperplasia (BPH) or to alleviate lower urinary tract symptoms could be very misleading to the public. Life-threatening cancers (cancer of the prostate and cancer of the urinary bladder) can cause lower urinary tract symptoms. The AUA is concerned that men experiencing such symptoms may self-medicate with food supplements containing saw palmetto, thus, delaying the timely and proper diagnosis of their cancers. The AUA is concerned that the package inserts accompanying these supplements, no matter what admonitions they might contain, are infrequently read by the user or, if read, are ignored or misunderstood.

The AUA is also concerned about the safety of food supplements containing saw palmetto for lower urinary tract symptoms. Most products currently being marketed in the United States for lower urinary tract symptoms and BPH are combinations of multiple ingredients. Each product is often different from the other. The various multiple components could differ within each individual product.

The AUA very strongly believes that each of these products marketed for lower urinary tract symptoms and BPH should be individually tested for safety given that each product could be different. Further, the AUA believes that each product should be tested for possible drug interactions with the wide variety of prescription medications (anti-hypertensives, anti-diabetics, mood-altering drugs, cardiac medications and other pharmacological agents), which are so commonly being taken by older men. Such testing and study could insure that a specific saw palmetto containing food supplement product poses no serious threat of adverse drug reactions when taken with other pharmacological agents. The AUA believes that there currently exists inadequate medical data ruling out possible serious interactions.

In a randomized, placebo-controlled, six-month study of 44 men with lower urinary tract symptoms and an enlarged prostate gland upon digital rectal examination, Marks and coworkers [1] reported no adverse events in his cohort of patients taking the herbal product containing saw palmetto, which was under study. However, an entry criteria into the study was that the men "be in good general and mental health." No data were given about the prescription medications those men on the herbal compound containing saw palmetto might have been taking at the time of the study. Thus, no data regarding prescription drug interaction can be gleaned from this small study since the men in this study were in good health and might not have been taking any such prescription medications.

Our Association believes it is inappropriate to cite the safety data on pure saw palmetto products currently marketed in Europe (such as Permixon not currently available in the United States) as proof of the safety of the mixed products containing saw palmetto being marketed in the United States. Permixon and the United States mixed products containing saw palmetto are not comparable, thus, making safety extrapolations scientifically invalid.

The mission of the American Urological Association through its members is to provide the highest quality of care to patients with genitourinary disease. In pursuit of this mission, the AUA continually maintains an open mind. However, the American Urological Association strongly believes that food supplements containing saw palmetto marketed for the alleviation of lower urinary tract symptoms, the treatment of BPH, and for the maintenance of prostate health should be controlled by the Food and Drug Administration (FDA) and held to the same standard as are all other pharmacological agents intended to treat disease.

The AUA believes that these food supplements containing saw palmetto should be carefully studied through properly controlled, perspective, randomized clinical trials under the auspices of the FDA as are all other pharmacological agents being marketed for disease control. Through such studies, the safety of food supplements containing saw palmetto can be assessed along with any possible drug interactions they might create.

Should proper studies confirm the safety and efficacy of food supplements containing saw palmetto, the AUA would welcome their addition to the armamentarium of American physicians treating men with lower urinary tract symptoms due to benign disease.

The American Urological Association strongly urges the Food and Drug Administration to control food supplements containing saw palmetto marketed to alleviate lower urinary tract symptoms, to treat benign prostatic hyperplasia or to maintain prostatic health. Proper clinical trials can resolve safety and efficacy issues. It is our understanding that the National Institutes of Health is actively considering setting in place clinical trials on saw palmetto and food supplement products in the treatment of lower urinary tract symptoms and benign prostatic hyperplasia. The American Urological Association applauds the concept of such studies and anxiously awaits their outcome.


Irwin N. Frank, MD, F.A.C.S.
President
American Urological Association


[1] Marks, LS, et al. Affects of Saw Palmetto herbal blend in men with symptomatic benign hyperplasia. Journal of Urology 2000 May; 163 (5), 1451-1456.

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