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The FDA announced, the “morning after” pill, Evital, could be fake and may not be safe or effective in preventing pregnancy. It has been marketed to Hispanic communities in the U.S., but it has not been approved by the FDA.
The suspect counterfeit version says “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet” by “Fluter Domull.”
Consumers should contact their doctors if they have taken a 1.5 mg tablet labeled “Evital” and experienced any problems.
The FDA is asking for help from consumers who have information about Evital.
Please send an email to [email protected] to provide information or if you have more questions.
There are FDA-approved emergency birth control pills available without prescription for women who are 17 and older, and there are also some available with prescriptions for those who are younger.
About emergency contraception:
Emergency contraception pills contain hormones to disrupt ovulation, and they should be taken within 72 hours after unprotected sex or contraceptive failure to prevent pregnancy.
Some physicians and pharmacists think that the pill may not always prevent pregnancy, and in some cases, the hormones within the pill just prevent the fertilized embryo from implanting into the womb. The data sheet for one brand of emergency contraceptive pill says:
“At the recommended regimen, levonorgestrel is thought to work mainly by preventing ovulation and fertilisation if intercourse has taken place in the preovulatory phase, when the likelihood of fertilisation is the highest. It may also cause endometrial changes that discourage implantation.”
The level of hormones in emergency "morning after" pills are often higher than those found in standard contraceptive pills.
Side effects of the “morning after” pill:
The most common side effects of the "morning after" pill are nausea, vomiting, vaginal bleeding that isn’t menstruation, headache, low abdominal pain, fatigue, breast tenderness, dizziness, diarrhea, and delay of menstrual period.
Other effects include rash, urticarial, pruritus and facial swelling. The “morning after” pill also increases the likelihood of ectopic pregnancy, and women with a history of ectopic pregnancy should not take it.
Women who have hepatic dysfunction or galactose intolerance should also not take this pill. Those with Crohn’s disease should be aware that it may not prevent pregnancy due to malabsorption.
Women who are taking barbiturates or the herbal remedy St. John’s Wort should seek advice from their doctor before taking emergency contraception because the effectiveness may be reduced.
This is just for one brand of pill, and it is advisable to read the patient information leaflet before taking the product in case the details are different.
Sources:
FDA Warning Announcement, 28th July 2011 - http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265847.htm
Levonelle One Step Emergency Morning after Pill Data Sheet - http://www.medicines.org.uk/emc/medicine/15227/SPC/Levonelle%20One%20Step#CONTRAINDICATIONS
Early Pregnancy Factor, page accessed 31st July 2011 - http://www.lifeissues.net/writers/dup/dup_01earlypregfacts.html
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.
Reviewed August 1, 2011
by Michele Blacksberg R.N.
Edited by Shannon Koehle
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