FDA warns unapproved emergency birth control may be ineffective, unsafe

August 19, 2011

FDA is warning consumers in the United States not to use an emergency birth control medicine labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.

FDA is warning consumers in the United States not to use an emergency birth control medication labeled as Evital. According to a recent press release from the agency, Evital has not been approved by FDA, and the product may be a counterfeit version of the morning-after pill. It may not be safe or effective in preventing pregnancy.

The packaging label of the potentially ineffective and suspect counterfeit version says, “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet,” by “Fluter Domull.” A picture of the packaging can be seen on the FDA website.

FDA is asking consumers who have information about Evital to send an email to CDER_Ingredient_Adulteration@fda.hhs.gov. FDA will treat any information it receives as confidential and will only use the information to help in its effort to remove the potentially unsafe and ineffective versions from the US marketplace.

Report adverse events related to the use of suspect counterfeit versions of Evital to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.