Plan B One-Step Contraceptive Approved by FDA for Girls Age 15? [Videos]
A federal judge ordered the U.S. Food and Drug Administration to make Plan B One-Step emergency contraceptive available for girls as young as 15 years old to be purchased without any prescription.
The ruling Brooklyn court approved the over-the-counter access of the drug "Plan B" which is used as an emergency contraceptive after 72 hours of unprotected sex. But according to FDA, it was a response to an amended marketing application from Teva Women's Health Inc. - a unit of Plan B maker Teva Pharmaceuticals Industries Limited.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies. The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly and that it does not prevent the transmission of a sexually transmitted disease," stated by FDA Commissioner Margaret Hamburg quoted by Reuters.
This announcement has been linked to the possible reverses of the December 2011 decision that prevented sales of emergency contraceptive to all females of reproductive age which was overturned by a U.S. district judge in New York on April 5, 2013.
Reproductive-rights groups cheered on over the decision while anti-abortion and religious groups criticises the approval.
Is Emergency Contraceptive Safe to Use?
According to the World Health Organization or WHO, there is no medical condition for which risks the consumer that can outweigh the benefits of using such drug. But for women with history of blood clots, stroke or migraine, it is preferable to combine estrogen with EP. Levenogestrel-alone ECPs are very safe and will not cause abortion or harm fertility.
Possible Side Effects?
The most common side effects of using emergency contraceptive is nausea and if a woman vomits within 2 hours after taking one, she should take a further dose as soon as possible. Other than nausea, ECP can cause abdominal pain, fatigue, headache, breast tenderness and temporary disruption of menstrual cycle.
How Often Should It Be Used?
ECPs are used only after unprotected sexual intercourse and designed for regular intake. ECPs may be safe but components may cause unforeseen effects if taken in enormous high dosage.