“Abortion” approval
August 17, 2010
THE US Food and Drug
Administration has approved ella
(ulipristal acetate) tablets for
emergency contraception.
The prescription-only pill is
designed to prevent pregnancy
when taken orally within the first
120 hours (five days) after a
contraceptive failure or
unprotected intercourse.
The agency has said however,
that the pill should not be used as
a routine contraceptive agent.
The move is rather rather
controversial in the US, with many
pharmacists and doctors objecting
to ella’s approval, saying that the
pill is not am emergency
contraceptive, but rather is a
method of abortion.
MEANWHILE the FDA has also
proposed the withdrawal of the
drug midodrine hydrochloride
(marketed as ProAmatine by Shire
Development Inc) which is used to
treat the low blood pressure
condition orthostatic hypotension.
The FDA has cited post-approval
studies “that verify the clinical
benefit of the drug have not been
done” as its reason for concern.
“We’ve worked continuously with
the drug companies to obtain
additional data showing the drug’s
clinical benefits to patients,” said
Norman Stockbridge, director of
the Division of Cardiovascular and
Renal Drugs in the FDA’s Center
for Drug Evaluation and Research.
“Since the companies have not
been able to provide evidence to
confirm the drug’s benefit, the
FDA is pursuing a withdrawal of
the product,” Stockbridge added.
Shire now has 15 days with
which to respond to request a
hearing with the FDA.
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