FDA Approves Five Days Emergency Contraceptive Pill

by Dr. Trupti Shirole on  October 15, 2010 at 6:26 PM Health Watch   - G J E 4
Ella, the new form of emergency contraceptive pill, prevents pregnancy if it is taken orally within 120hours (5days) after unprotected intercourse or contraceptive failure.

Ella has been approved as a prescription only- medication and is not intended for routine use as a contraceptive. It works as efficiently on the fifth day as on the first day after sex. Studies have shown that women who took Ella within 3-5days of unprotected intercourse still had a 1.8% chance of becoming pregnant. But the pill does not protect against HIV and STDs.

Ella is formulated as a 30-mg tablet. It is a progesterone agonist/antagonist. Progesterone delays or inhibits ovulation.

Certain groups including the Family Research Council argue Ella to be a chemical relative to RU-486 (mifepristone), the abortion pill. There is some evidence that Ella reduces, or thins, the lining of the uterus thus making the womb less hospitable for a fertilized egg (zygote).to be implanted.

Animal studies indicate that Ella had little effect on existing pregnancy, thereby differentiating it from the abortion pill.

The Reproductive Health Drugs Advisory Committee of the FDA unanimously approved the pill. There is no scientific evidence that if the drug is taken in the recommended 30-mg dosage, it causes abortion.

The most common side effects observed with Ella in the clinical trials include:

• mild to moderate headache,

• nausea,

• abdominal pain,

• pain/discomfort during menstruation (dysmenorrhea), 

• fatigue and dizziness.

These side effects are quite similar to FDA-approved levonorgestrel emergency contraceptives. The FDA reviewers reported no life-threatening side effects with ella.

Ella is contraindicated (must be avoided) in women with known or suspected pregnancy and also while breast feeding. 

Women who conceive or complain of lower abdominal pain after taking Ellashould be ruled out for ectopic pregnancy, where the foetus develops in the fallopian tube and not the uterus. Menstruation patterns may be altered after the use of Ella. But if menses is delayed for more than a week then the woman must be ruled out for pregnancy.

Ella is to be marketed by Watson Pharmaceuticals in the United States who hope to make Ella available by this year end. The price of the medicine is yet to be announced.

Source: Medindia

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