FDA Warns Against Counterfeit Morning-After Pill

Emma Hitt, PhD

Disclosures

July 29, 2011

July 29, 2011 — The US Food and Drug Administration (FDA) is warning today against the use of an unapproved “morning-after” pill called Evital that may be in distribution, especially in some Hispanic communities, in the United States.

Evital is not been approved for use in the United States.

The warning was released July 29 by the FDA Center for Drug Evaluation and Research’s Division of Drug Information. According to the FDA, the packaging label of the potentially ineffective and suspect counterfeit version says, "Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet." It is manufactured by Fluter Domull.

There are FDA-approved emergency birth control medications that are available both by prescription and over-the-counter for individuals aged 17 years old or older, the agency states.

The FDA is requesting that people who are familiar with this product send an email to CDER_Ingredient_Adulteration@fda.hhs.gov to provide information or to ask questions about this product.  

"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 notes.

Adverse events related to these products can also be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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