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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 people 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 - Propecia 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 - the inability to have or maintain an erection
- Decreased libido (no sex drive) or decrease in amount of ejaculate
If you notice other effects not listed above, contact your doctor.
If you experience any of these symptoms - changes in the breasts such as lumps, pain, or nipple discharge - call your doctor immediately.
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 does not include everything there is to know about the medicine mentioned above. Do not use this medicine without first talking to your doctor. Other brand names or generic forms of this medicine may also be available. Side effects other than those listed above may occur. This medicine may be prescribed for other uses. If you have questions or concerns, or want more information, your doctor or pharmacist has the complete prescribing information about this medicine and possible drug interactions.