Us Fda Approves Controversial Contraceptive Pill Ella

THE US Food and Drug Administration (FDA) on Friday approved the controversial morning-after pill 'Ella'

. The contraceptive medicine extends the post-sex pregnancy prevention for upto five days. The medicine developed by French company Laboratoire HRA Pharma is already available in Europe, since May 2009.

The drug which is issued only on subscription and is thought to work by inhibiting or delaying ovulation, according to a statement from the FDA. The approval for this drug came after an agency advisory committee unanimously supported Ella's approval in June. Other agencies that backed FDA's decision included 'Planned Parenthood'.

The side affects associated with Ella are similar to that of other emergency contraceptives, pointed out the FDA. Some of the symptoms are headache, abdominal pain, nausea, pain/discomfort during menstruation (dysmenorrhea), fatigue and dizziness. Although it prevents pregnancy, the drug is not recommended for women, who are pregnant or for women who are breast-feeding.

After reviewing the medicine, the FDA in a statement said, the safety and efficacy of Ella were demonstrated in two phase clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

But like many other medicines available, Ella too has its own detractors. Experts believe that the drug works by delaying the ability of ovaries to produce an egg. However, opponents note that progesterone is also required to help the womb prepare for an already fertilized egg - raising the possibility that the drug works similarly to RU-486, which prevents a fertilized egg from implantation in the womb.

The group's President Cecile Richards said in a statement that every woman deserves every option available to prevent an unplanned pregnancy. Richards further said that there are many reasons why a woman may face the risk of unintended pregnancy, from failure or improper use of birth control to sexual assault. The FDA's approval of this new form of emergency contraception gives women one more option.

by: Merinews

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