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Finasteride - Propecia ®
FDA Approves Finasteride to Treat Male Pattern Hair Loss in Men
Finasteride is the active ingredients (pronounced - fi-nas'-teer-ide).
Propecia ® is the brand name.
The Food and Drug Administration (FDA) approved Propecia ® for hair loss, making it the first such treatment for men in pill form. The following can be used to answer questions:
* The active ingredient in Propecia ® is finasteride.
* Finasteride was approved initially in 1992 as Proscar ®, a treatment for prostate enlargement.
* There is 1 mg of finasteride in Propecia ® and 5 mg in Proscar ®.
* It was observed that some patients being treated for prostate enlargement had some regrowth of hair in areas of male pattern hair loss.
The sponsor studied 1 mg of finasteride and demonstrated hair growth in male pattern hair loss. The number of hairs increased in the anterior midscalp and vertex. Patient self-assessment of hair growth was also superior to placebo. Side effects were infrequent and were related to sexual function.
Finasteride will not be marketed for women because it causes birth defects, and the safety and efficacy have not been established in women.
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee discussed Propecia ®. The committee offered labeling suggestions in the context of an overall generally favorable discussion. Merck & Co. of West Point, Pa., manufactures both Proscar ® and Propecia ®, both registered trademarks of Merck & Co., Inc.
DRUG CLASS AND MECHANISM:
AVAILABILITY: This medicine can only be prescribed by a licensed healthcare professional
APPROXIMATE COST: $45 to $50 per month
INDICATED FOR: Men only
DOSING: Tablet taken once a day
SIDE EFFECTS: Possible side effects include impotence (inability to have or maintain an erection), decreased libido (no sex drive) or decrease in amount of ejaculate. If you notice other side effects not listed, contact your doctor. If you experience any of these symptoms, call your doctor immediately: changes in the breasts such as lumps, pain, or nipple discharge. Possible side effects other than those listed may occur.
References:
FDA TALK PAPER - Food and Drug Administration - U.S. Department of Health and Human Services - Public Health Service 5600 Fishers Lane Rockville, MD 20857 - December 1997 - www.fda.gov
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
This summary is a general overview about the topic discussed and does not include all the facts, or include everything there is to know about any medicine and/or products mentioned. Do not use any medicine and/or products without first talking to your doctor. Possible side effects of medications, other than those listed, may occur. Full Disclaimer & General Safety Advisory