Monday, August 16, 2010

FDA Approves EllaOne for Usage in the United States

FDA Approves New Form of Emergency Contraception

There is a new form of emergency birth control coming to a perscription near you.  The Food and Drug Administration (FDA) has approved the use of Ella, or EllaOne, as another option to prevent unwanted pregnancies within 5 day of unprotected sex. EllaOne has been successfully approved and used in some European countries, and will be available in the United States some time in September.

There has been a great deal of discussion around it being the new 'over-the-counter abortion' pill. Those discussions, all though very relevant, are not up for debate here. Ethically sound or not, I am looking at the medical aspect. I want to get into the concerns around the side effects and other medical aspects of the drug itself.

According to my research, it has been said more than once that the drug is not to be used as a permenant form of birth control. The side effects alone seem more than convincing of that idea, however, the effects on the body should, in this researcher's opinion, be more than enough to be a warning label. Granted, most drugs that are given to patients come with the same warnings, the patient must decide for themselves if this particular drug is worth taking.

The FDA has said that their clinical trials found the medication to be safe as well as effective. However, they do caution that it is not to be taken as routine usage. They did find that the most noted side effects were: headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. And, according to the FDA, most emergency contraceptives have these same adverse effects.

One caution the FDA does provide is that it has not tested this new product on individuals under the age of 18. It has also been noted that there has not been any research on the long-term effects of this drug, especially muliple uses. The Family Research Council has noted that six years after the RU-486 emergency contraceptive was legalized, there were "6 deaths, 9 life-threatning incidents, 232 hospitalizations, 116 cases needng blood transfusions and 88 infections."

In the end, as with any medication, new to the market or not, one should consider the side effects and be cautious regarding taking such new items. If you have any concerns regarding your personal health and taking the EllaOne, or any other form of contraception or other medication, please consult your doctor. They are the best resource you have for determining if any medication would post a threat to you or not. If you would like to find out more about the EllaOne or any other medication on the market, you can contact the FDA directly.

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