Nov 14, 1997-A Food and Drug Administration committee met Thursday and
gave an initial thumbs up to Propecia, Merck's anti-baldness drug,
while raising questions about its long-term side effects.
committee was considering the one-a-day pill known as Propecia,
to determine whether it is both safe and effective. Advisers
told the FDA that Propecia appears to help some men grow new
the FDA panel stopped short of give a total endorsement of Merck & Co.'s
new pill raising questions over whether men who took the pill
for years would suffer fertility problems and other unforeseen
panel, without a vote, concluded that the pill was effective
and left the safety question to the government. Now it is up
to the FDA to decide whether to require Merck to extend the study
of the drug or allow its sale and keep tabs on what happens to
balding men over time. If approved, it could be available by
the end of the year.
Propecia is a once-a-day pill that promises to help regrow hair
-- and prevent more from falling out -- by suppressing a hormone
that shrinks hair follicles.
actually is a lower dose of a popular drug that men already use
for enlarged prostates, called Proscar. For the merely hair-impaired,
Merck says a safe dose is 1 milligram a day of the active ingredient,
finasteride, not the 5-milligram Proscar pills that prostate
patients take. The company also claims that serious side-effects
already would have emerged in the millions of older men who take
the 5-milligram pill to shrink enlarged prostates.
although women suffer hair loss, too, Merck says Propecia can
never be used by them -- the threat of birth defects is too great.
Doctors even tell women not to touch the pills for fear the drug
could be absorbed through their skin.
showed the FDA's scientific advisers studies of 1,553 men that
found 86 percent of those who took Propecia grew more hair or
maintained the amount they had, compared with just 42 percent
of men who took a placebo.
spent two years counting the hairs in specific sections of men's
scalps, and those who didn't get Propecia treatment lost 2.5
percent of their hair every year, while hair counts were stable
for the treated men.
the big question for the FDA, is whether using a pill that affects
hormones is safe for a simply cosmetic problem.
says side effects included decreased libido and impotence in
2 percent of the men who took Propecia, a number that seems insignificant,
since 1.3 percent of men who took the placebo experienced reported
the same problems.
works by blocking production of a testosterone-related hormone
called dihydrotestosterone, or DHT, that causes hair loss.
Propecia can cut men's DHT levels by 60 percent, greater results
have been seen in men who used both Propecia and Rogaine