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'Morning-after
pill' to be sold in U.S. markets next year posted 10-20-97 A New Jersey pharmaceutical company has announced plans to market the first oral birth control product in the United States that’s specifically intended for use as an emergency contraceptive. Gynetics Inc. plans to sell its "morning-after pill" for prescription use in 1998. Essentially a repackaged version of common oral contraceptives, the morning-after pill works just like the standard pill—it inhibits ovulation, prevents implantation of a fertilized egg into the uterus wall, and disrupts movement of the ovum though the fallopian tube. Unlike the controversial abortion pill RU 486, this method has no effect on an established pregnancy. The Food and Drug Administration cleared the way for the new product in February, when it approved six brands of combined oral contraceptives for "off-label" use, meaning using the drug in ways or dosages not originally intended or approved. The Gynetics product will provide new drug indications and consumer instructions indicating that it’s designed for emergency use only. Taken up to 72 hours after intercourse, the regimen is effective about 75 percent of the time. For every 100 women who have unprotected sex during the second or third week of their menstrual cycle, eight would normally become pregnant, but only two would become pregnant if the women used the emergency birth control. Researchers have found no serious side effects, although vomiting and nausea commonly occur. "FDA approval is a great step forward," said Susan Wysocki, RN, president and CEO of the National Association of Nurse Practitioners in Reproductive Health. She urged nurses to help educate patients about emergency contraception "so they’re aware that if they have intercourse and don’t use protection, they have this available to them." Abortion opponents have criticized the new product because it works after an egg is fertilized. Greg Clements, Gynetics’ executive vice president of sales and marketing, said the product technically prevents, but does not terminate, pregnancy. Until now, such politically charged debate deterred U.S. drug makers from marketing their versions of the emergency contraceptive pill in this country. The pills are routinely prescribed overseas. Related Site |