Americans United for Life | AUL Urges the FDA Not to Approve the Drug Ella
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AUL Urges the FDA Not to Approve the Drug Ella

AUL Urges the FDA Not to Approve the Drug Ella

A member of the ella Causes Abortion Coalition, Americans United for Life co-signed a letter that was sent yesterday to the Commissioner of the Food and Drug Administration (FDA) asking the administration not to approve the new drug, ella.

Ella is being marketed as an “emergency contraceptive,” but it is the “next generation” of the abortion drug, RU-486.  Ella, like RU-486, is a selective progesterone receptor modulator (SPRM).  As a progesterone blocker, an SPRM works to interfere with the developing human embryo, causing it to die by either interfering with the uterine lining and preventing implantation, or by starving an implanted embryo.

Women deserve to be fully informed that ella may interfere with and kill a developing embryo and does not simply prevent conception.

In June, several members of the FDA advisory panel that reviewed ella’s application raised the concern that there was insufficient data to show the effect ella would have on a pregnancy and a developing embryo or fetus.   However, at the end of the meeting, the panel inexplicably voted unanimously in favor of approving the drug as a contraceptive, and specifically recommended that the FDA not require a pregnancy test before dispensing ella.

Serious concerns also exist about ella’s risk to women’s health.  Ella’s chemical make-up and mode of action are very similar to RU-486, which is known to cause serious adverse health risks such as severe bleeding, ruptured tubal pregnancies, serious infections, and even death.  Further study is necessary to ensure ella is safe for women, particularly if it is used off-label.

The FDA summary also indicates that the clinical study on ella was too limited to draw any meaningful conclusions about risks associated with tubal pregnancy. Little data is available about ella’s effect on minors or complications from ella’s interaction with other drugs, such as hormonal birth control.

In light of these and other serious concerns detailed our coalition’s letter to the Commissioner we urge the FDA not to approve ella.

More information on ella is available at the ella Causes Abortions coalition website: www.ellacausesabortions.com

29 Jul 2010
 
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