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Panel backs OTC switch for Plan B: emergency contraception.
GAITHERSBURG, MD. -- If the levonorgestrel-only emergency contraceptive becomes available over the counter, as was recommended by a Food and Drug Administration advisory panel, this option could halve the number of unintended pregnancies and abortions that occur in this country each year, according to some estimates.
At a joint meeting of the FDA's nonprescription drugs and reproductive health drugs advisory committees, the panel voted 234 in favor of the OTC switch for the product, which is marketed as Plan B.
The product--which includes two 0.75-m levonorgestrel tablets, one taken within 72 hours of unprotected intercourse and the second 12 hours later--was approved in 1999 and was the first emergency contraceptive (EC) to contain only progestin. Preven, an EC product that contains levonorgestrel and ethinyl estradiol, was approved in 1998.
When taken within 72 hours of one act of unprotected intercourse, Plan B can reduce the chance of pregnancy by 89%, but if taken within 24 hours of unprotected intercourse, it can reduce the risk of pregnancy by 95%, Dr. Carole Ben-Maimon, president and chief operating officer of Barr Research, said at the meeting.
(Plan B's manufacturer, Women's Capital Corporation, which filed for approval for the OTC switch, is in the process of being acquired by Barr Laboratories.)
Plan B is thought to work primarily by delaying ovulation or preventing fertilization, although it is possible that it may inhibit implantation of a fertilized egg by altering the endometrium. The company maintains that it is not an abortifacient, but a contraceptive. There is no evidence that it is harmful to an established pregnancy, she added.
To date, more than 7,000 women have used Plan B in clinical trials, Dr. Ben-Maimon said. In the United States, 2.4 million women have used it since approval, and products identical to Plan B have been used by 2.1 million women in the United Kingdom and by 1.8 million women in France, according to the FDA.
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Source: HighBeam Research, Panel backs OTC switch for Plan B: emergency contraception.