Ella approved for emergency contraception: what you need to know
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The Food and Drug Administration announced on Aug 13 that it has approved ella tablets for prescription emergency contraception, or birth control.
Some view the approval as good news for women's sexual health; others are concerned that this drug could lead more people to engage in unprotected intercourse.
As an emergency contraceptive, Ella prevents pregnancy when taken orally within five days of unprotected intercourse or birth control failure.
Ella, made by Paris-based Laboratoire HRA Pharma and distributed by Watson Pharma Inc., of Morristown, N.J., is a progesterone agonist/antagonist; it works to inhibit or delay ovulation, the FDA says.
But some health observers suggest that the birth control pill can do more than merely delay ovulation. Some are concerned that the drug may cause abortion.
The FDA approval is based upon data regarding the safety and efficacy of ella from two phase III clinical trials. One was conducted in the United States and the other in the United Kingdom and Ireland. The medication is said to be more effective than plan B, which is available now over the counter for women age 17 and older.
The 5-day emergency contraception medication has been available since May 2009 in Europe under the brand name EllaOne.
Like all other drugs, this pill can cause side effects, including headache, nausea, abdominal pain, pain/discomfort during menstruation, fatigue, and dizziness, according to the FDA.
Ella is controversial because it is viewed by some anti-abortion groups as the means to a particular end: ending unwanted pregnancy.
Groups including the Family Research Council are concerned that the drug could lead to abortion because it is chemically similar to RU-486, which can end a pregnancy up to 50 days into the gestation period, according to The Huffington Post.
What Every Needs to Know Before Taking Ella
In any case, here are some common questions consumers typically have, regarding ella; this information is described in patient labeling approved by the FDA.
What is Ella?
ella is a prescription emergency contraceptive indicated as a remedy either for failed birth control or as a precaution after unprotected sex. The contraceptive does not protect women against infection of HIV and other sexual transmitted diseases.
Who should not use ella?
Those who know or suspect they are already pregnant should not use ella, as it is not intended to use in an effort to abort pregnancy. Those who are breastfeeding should also avoid ella, as it is unknown whether this contraceptive would get into breast milk affecting the baby.
What do doctors need to know before they give you ella?
Doctors need to know whether you are taking medications, vitamins or herbal supplements; these include St. John's Wort Phenytoin, rifampin, ogenobarbital and carbamazepine - many substances can affect how ella works.
Additionally, doctors need to know if you are taking regular hormonal birth control pills, which could make ella less effective.
What do I need to avoid after taking ella?
Unprotected sex- in other words, you should use a reliable birth control measure whenever you have sex in the same menstrual cycle.
When should I avoid using ella?
Do not rely on ella as a regular contraceptive. It is intended to be used only as an emergency contraception measure.
Don't use ella if you are pregnant; doing so could hurt harm a developing baby. The patient information states there is little information about whether the drug would affect a developing baby.
Don't use ella if you have already used it once during the same menstrual cycle.
How does ella work?
"ella is thought to work for emergency contraception primarily by stopping or delaying the release of an egg from the ovary". This is what the patient information says. The contraceptive may also prevent a fertilized egg from attaching to the uterus.
How should I take ella?
Take ella as soon as possible within five days of unprotected intercourse, or if you experience birth control failure.
The drug can be taken alone or with food, and can be used at any time during a menstrual cycle.
What should I do if I vomit after taking ella?
Contact your doctors right away of you vomit within three hours of taking ella. Doctors may give you another dose.
How effective is ella?
It is not effective in every case and it is less effective in women with a body mass index of greater than 30 kg/m2, or, in other words, obese women.
What are the side effects of ella?
ella can cause a number of side effects including headache, nausea, stomach pain, menstrual pain, tiredness and dizziness.
For more information, talk to your doctor or pharmacist.
By Jimmy Downs and editing by Rachel Stockton
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