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ABSTRACT FROM ARTICLES ON HAIR LOSS
| TITLE |
- FDA COMMITTEE ACCEPTS EFFICACY OR PROPECIA
|
| SUMMARY FROM |
- West Point, PA, 11/13/97 PRNewswire
|
| AUTHOR |
 to be
updated
|
| THE ARTICLE TALKS ABOUT: |
- The advisory committee of the US FDA (Food and Drug
Administration) concluded that Propecia is effective in treating male pattern baldness.
Now it is up to the FDA to give the drug its seal of approval. A New Drug Application will
be submitted to the FDA by Merck & Co on December 19, 1997.
- Propecia is the brand name drug manufactured by Merck & Co.
- Although the FDA normally follows the advice of the advisory
committee, there are concerns about fertility, potency and birth defects that may impair
the outcome of the final decision.
- Three clinical studies were presented to the advisory committee
by Merck & Co to substantiate the effectiveness of the drug.
- A total of 1,879 male participants with varying degrees of hair
loss were involved in clinical studies conducted by Merck & Co. After a period of 24
months, a majority of the participants (86%) reported either hair growth or cessation of
hair loss.
- The drug works by blocking the enzyme 5-alpha reductase in our
body. The presence of the enzyme will convert the male hormone testosterone into DHT - a
more potent derivative of testosterone which is believed to be the main cause of male
pattern baldness.
- Because of the drug's impact on male hormone, a small percentage
of the participants experienced a decrease in libido and potency. The drug will not be
marketed to women due to its potential side effects relating to fertility and birth
defects.
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