In the US more than 500,000 women
give birth prematurely, and many of
the babies don't survive. Those who
do are at an increased risk for many
health problems, including mental
retardation, cerebral palsy and autism.
USING A PROGESTERONE GEL WILL
CUT THE RISK OF PREMATURE
Using a progesterone gel in certain
pregnant women in danger of
delivering too early may cut that risk by
45%, according to a new study by the
National Institutes of Health.
The women who participated in the
study had a short cervix, which has
been associated with preterm delivery
and is thought to be a sign of low
About 3% of all women have a cervix
between 10 millimeters and 20
If the cervix is 15 millimeters long or
less, the risk of delivering before 33
weeks is about 50%.
The study randomly assigned 465
healthy pregnant women at 44 medical
centers in 10 countries to receive
either an 8% progesterone gel, to be
administered daily beginning about
midway through the pregnancy, or a
Of the women treated with the
progesterone, 8.9% delivered before
33 weeks of gestation, versus 16.1%
of women using the placebo. The
33-week cutoff was used because
babies born before that are more likely
to experience problems than those
born closer to term.
The formulation of the progesterone
gel used in the study is currently
approved by the Food and Drug
Administration. It was developed by
Columbia Laboratories and marketed
in the U.S. by Watson Pharmaceuticals.
Columbia says it plans to submit a new
drug application to the FDA for this
use of the gel, which it's calling
Prochieve, in the second quarter of
MAKENA DRUG'S PRICE CUT
KV Pharmaceutical of St. Louis
announced it was cutting the price of
the drug, sold as Makena, to $690 an
injection. In addition, KV said it was
expanding its program to help women
who still are having trouble affording
"The proposed price reduction doesn't
go far enough to protect public health"
Rep. Louise M. Slaughter (D-N.Y.)
said. "This medication is still almost 50
times what it was a month ago."
The Food and Drug Administration
took the unusual step of announcing
that it would not stop pharmacies from
continuing to produce less expensive
versions of the drug, which had long
been available for $10 to $20 a dose.