FDA report on RU-486 adverse effects (2011)

FDA Q&A on RU-486 (2011)

Deaths associated with RU-486

USCCB Summary Fact Sheet on RU-486

What the FDA says about RU-486

The RU-486 Abortion Process

RU-486 (Mifepristone) is a synthetic steroid used to induce abortion between the fourth and seventh week of pregnancy. RU-486 is normally used in conjunction with a prostaglandin (like misoprotol) which induces uterine contractions to increase its abortive efficacy (95%). Taken alone RU-486 can have a 20%-40% failure rate.

RU-486 works by inhibiting the natural functions of the hormone progesterone. Progesterone is produced in the ovaries and helps the endometrium (uterine lining) nurture the embryonic child. Because RU-486 resembles progesterone, but does not function like it, the endometrium breaks down, and thus it, and the growing child is shed from the uterus.Taking RU-486 induces the miscarriage of pregnancy, it does not simply induce menstruation.

The process of an RU-486 abortion, though not surgical, is nonetheless arduous. Women must make three or four trips to the abortion facility. Taking RU-486 is followed up two or three days later with a trip to take the prostaglandin drug. At a minimum, a third trip is required to confirm that the abortion has occurred. A particularly disturbing aspect of an RU-486 abortion is that women may expel their unborn children at home, often being alone, and sometimes being able to identify the developing child amid the uterine contents they miscarry.

RU-486: Complications and Long-term Effects

Use of RU-486 does not come without dangers. Prolonged bleeding, severe cramping, nausea, diarrhea, headache, skin rash and vomiting are common side effects. About 5% of the women bleed so heavily that a D&C or other treatment is required. Two women taking the drug have had heart attacks, another woman died, prompting the French government to review the drug’s use for older women and smokers.

For about 5% of the women using the RU-486/misoprostol technique, the abortion fails to occur. These women must then have a surgical abortion. Medical evidence indicates that a child which is not aborted by RU-486 faces the possibility of malformations due to the drug. In Europe, women taking RU-486 are often required to sign a form requiring them to obtain a surgical abortion if the drug fails.

The study done here in the United States on RU-486 was conducted on women ages 28 to 45 years. Despite the fact that the FDA does not know the effects of RU-486 on women under 18, the drug will be available to them.

The long-term effects of RU-486 are completely unknown. It does have chemical properties similar to DES, a drug taken for miscarriages in the 1960s and 1970s, which has had serious long-term effects on women’s health. No information is available about repeated exposure to RU-486. If the pattern for surgical abortions (a repeat rate of 47%) is assumed for RU-486, women may end up taking the drug repeatedly.

RU486 in the news

Federal judge OKs Ohio regulations on dangerous RU486 drug

Planned Parenthood continues to violate FDA guidelines for RU486


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