Pharmaceutical International News - August 2011

FDA Evital Emergency Contraceptive Warning

Posted by Pharmaceutical International's Senior Journalist on 01/08/2011 - 15:15:00

Emergency Contraceptive

The US FDA has issued a consumer warning covering Evital - an emergency birth control drug that's not been approved for use.

Possibly in circulation in the US, Evital has not been cleared by the US Food and Drug Administration and, so, represents a potential risk.

The Evital warning emanated from the Division of Drug Information within the agency's Center for Drug Evaluation and Research at the end of July 2011.

The label supplied with the product at the centre of the FDA's concern states that it's manufactured by a firm called ‘Fluter Domull', while the drug itself is described as ‘Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet'. The use of the Spanish language may mean that supplies of this birth control drug are particularly abundant within Hispanic areas of the US, the FDA suggested.

Evital Emergency Contraceptive

While the Evital emergency contraceptive is thought to be counterfeit and not guaranteed to be effective, there are genuine, approved products that women living in the US, who are over 17, can get on an over-the-counter basis.

This option isn't available for those under 17, who need to be formally prescribed with an emergency contraceptive, instead.

From here on in, the administration is asking members of the public with any information on Evital to contact them, using the email address CDER_Ingredient_Adulteration@fda.hhs.gov.

FDA Evital Warning

"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 US marketplace", the FDA said, in its Evital warning, adding that anybody who had actually taken the drug in 1.5mg form should seek medical advice.

In our most recent contraceptive pill coverage, Enviro News presented the results of US research that suggested a higher level of exposure to breast cancer existed in Africa-American women taking birth control medications.

Prior to that, we covered a new morning-after pill, potentially able to help women suffering from uterine fibroids.

Image copyright Anka Grzywacz - Courtesy Wikimedia Commons

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