• Additional phytochemical analyses to identify the biologically active components should be a high priority. Once biologically active components are identified, further biological evaluation should be conducted. Safety concerns should be revisited upon identification of additional components.

• There is a need to establish the mechanism of action of saw palmetto preparations.

• There are insufficient data to conclude that there are no drug interactions between saw palmetto preparations and conventional prescription drugs.

• Studies to establish the effects of saw palmetto products on bleeding times could shed additional light on the possible causal relationship of saw palmetto to the single clinical case report of excessive bleeding during surgery.

• Studies could shed light on the possibility of detrimental effects on the fetus.

Bowman CJ, Barlow NJ, Turner KJ, Wallace DG, Foster PMD. 2003. Effects of in utero exposure to finasteride on androgen-dependent reproductive development in the male rat. Toxicol Sci 74:393–406.

Clark RL, Antonello JM, Grossman SJ, Wise LD, Anderson C, Bagdon WJ, Prahalada S, MacDonald JS, Robertson RT. 1990. External genitalia abnormalities in male rats exposed in utero to finasteride, a 5 alpha-reductase inhibitor. Teratology 42:91–100.

Clark RL, Anderson CA, Prahalada S, Robertson RT, Lochry EA, Leonard YM, Stevens JL, Hoberman AM. 1993. Critical developmental periods for effects on male rat genitalia induced by finasteride, a 5 alpha-reductase inhibitor. Toxicol Appl Pharmacol 119:34–40.

GlaxoSmithKline. 2001. Approval Package. Duagen (Dutasteride) Soft Gel Capsules. Pharmacology Reviews. Online. Available at http://www.fda.gov/cder/foi/nda/2001/21319_Duagen.htm. Accessed January 8, 2003.

Thomson PDR. 2004. Physicians’ Desk Reference. 58th ed. Montvale, NJ: Thomson PDR.