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FDA issues warning on counterfeit EC
Alert your patients of a counterfeit form of emergency contraception (EC), labeled as Evital. The Food and Drug Administration (FDA) has issued a warning on the drug.
Evital was discovered through routine imports entry review, says Shelly Burgess, a FDA spokesperson. The agency is working to find out more about the apparently illegal U.S. distribution of what FDA suspects is a counterfeit product, Burgess states.
The packaging label of the suspect drug says, "Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet" by "Fluter Domull." The emergency birth control might be in distribution in some Hispanic communities in the United States, according to the FDA.
"We don't have evidence of pattern targeting a particular ethnic group: counterfeit and illegal drugs pose a risk to all U.S. consumers," says Burgess.
How can you help your patients avoid using this counterfeit drug? Visit the FDA web site,www.fda.gov. Under "News and Events," select "Newsroom," "Press Announcements," then the July 28, 2011, press release, "Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe." The press release contains a color picture of the suspect drug packaging that you can show patients as an illustration.
Consumers who have information about Evital should contact the FDA by sending an e-mail to CDER_Ingredient_Adulteration@fda.hhs.gov. Any information received will be treated confidentially by the agency and will be used only to help in FDA's effort to remove the suspect drug from the U.S. marketplace.
Healthcare professionals are asked to report adverse events related to the use of suspect counterfeit versions of Evital to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. Reports can be submitted online at www.fda.gov/MedWatch/report.htm. The form also can be downloaded by going to www.fda.gov/Safety/MedWatch. Instructions are included on the page. Those without computer access can call the agency at (800) 332-1088 to request a reporting form, which can be completed and returned to the address on the pre-addressed form or submitted by fax to (800) 332-0178.
Seize the moment
Should questions arise about Evital from your patients, use it as a moment to discuss and provide advance prescription of EC, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School Of Medicine at the University of California in Los Angeles. It also can provide an opportunity to discuss use of the Copper T380A intrauterine device (ParaGard IUD, Teva Women's Health, North Wales, PA) for EC, she notes.
Discuss the three dedicated emergency contraceptive pills now available in the United States: Plan B (Teva Pharmaceuticals, Woodcliff Lake, NJ), Next Choice, and ella, both marketed by Watson Pharmaceuticals, Parsippany, NJ. Plan B One-Step and Next Choice are available at pharmacies without a prescription to women and men 17 and older. Younger women may obtain Plan B One-Step and Next Choice from a pharmacy or clinic with a prescription. Nine states (Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont, and Washington) allow licensed pharmacists to directly dispense EC to women without advance prescriptions. A prescription is required for women of all ages to obtain ella.
Why advance Rx?
A recent review of available literature suggests that among women 24 years of age or younger, advance provision of emergency contraception has a positive impact on use and time to use of EC.1
According to the review, most studies found that women assigned to advance provision of EC did not engage in more sexual risk-taking behaviors, as assessed by reported number of sexual partners, number of episodes of unprotected intercourse, and acquisition of sexually transmitted infections, or switch to less reliable contraceptive methods. Despite increased use and decreased time to use, women who were provided EC in advance did not report significantly lower pregnancy rates.1
The Copper T IUD is a highly effective method of emergency contraception, and it can be used as ongoing contraception for up to 10 years. However, findings from a recent small study of young women who visited a reproductive health care clinic in search of EC indicate that women need better information and education about the IUD as a EC option.2
Most women in the study had an unrealistically high expectation about efficacy of the emergency contraceptive pill, report researchers, who said they lacked knowledge of the IUD as an EC option. Showing the IUD during counseling might help correct misconceptions and would improve acceptability to the method, the researchers state. Wider availability of expertise concerning use of the IUD for emergency contraception is essential to assist more women in making informed decisions when choosing a method for EC, they conclude.2