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Warning of Bogus Birth Control Pills

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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 CDER_Ingredient_Adulteration@fda.hhs.gov 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.

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