Government officials sent out an urgent warning today telling women not to take an unapproved product, which is marketed as emergency birth control medicine, claiming it may be ineffective and unsafe.
The U.S. Food and Drug Administration announced the drug Evital, which has not been approved for use in the United States, is being distributed under a counterfeit label.
The packaging label of the potentially ineffective and suspect counterfeit version of the drug says, "Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet."
It is manufactured by Fluter Domull, according to the FDA’s Center for Drug Evaluation and Research’s Division of Drug Information.
Fake versions of the drug are now being distributed illegally across the United States, including in some Hispanic communities.
Many people call emergency contraception the "morning-after pill." But that name is a little confusing. Women can use emergency contraception up to five days after unprotected intercourse – not just the "morning after."
Evital is commonly referred to as the morning-after pill. Other companies market the drug under the brand names Plan B One-Step, ella, and Next Choice.
“If there are counterfeit samples of this drug out on the street then our communities could see an increase in abortion rates and high school drop-out rates. This would destroy lives and pose potentially life-threatening complications for our people,” said Dr. James Whitmore, a retired evangelist in Mobile, Ala.
Emergency contraception, or EC as the morning-after pill is called, is simply a higher dose of regular birth-control pills taken within 72 hours of unprotected sexual intimacy – whether as a result of rape, contraceptive failure, or failure to use contraception, according to U.S. Health officials.
There has been much talk in the media about the morning-after pill and the FDA’s announcement about the illegal circulation of the counterfeit drug has stirred up even more debate.
Controversy is already thick as the decision to approve the morning-after pill was mired in debate over such fundamental questions as when life begins and the line between preventing and terminating a pregnancy, according to recent media reports.
Opponents of the morning-after pill worry that the drugs are becoming too easily availabile at the local pharmacy and the drugs are encouraging more irresponsible sexual behavior, especially among young people.
It is true that the morning-after pill may act as a contraceptive; if it is taken before ovulation, it may act to prevent conception.
But if the pill is taken during or after ovulation, conception may and frequently does occur and then, the makers of the morning-after pill freely admit, it acts by preventing implantation of the newly-formed embryo into the uterine wall.
Pro-life physicians say this mode of action is not contraceptive because it does not prevent conception, but rather, this aborts the life of a week-old human being.
“Prescribing or consuming this pill, therefore, is a reckless disregard for human life, all of its contraceptive potential notwithstanding,” according to the Association of Pro-Life Physicians.
For women who have taken Evital, the FDA urges them to call their doctor.
"Any information received is confidential and will be used only to help in FDA’s effort to remove the potentially unsafe and ineffective versions from the U.S. marketplace," the FDA said in its announcement today.
The FDA is asking for help from consumers who have information about Evital.
Send an email to CDER_Ingredient_Adulteration@fda.hhs.gov to provide information or for questions.