ROANOKE TIMES
Copyright (c) 1997, Roanoke Times
DATE: Tuesday, February 25, 1997 TAG: 9702250112
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Associated Press
American women who are raped, whose birth control fails or who just forget in the heat of the moment can use high doses of ordinary birth control pills to prevent pregnancy, the government said Monday.
The Food and Drug Administration said six brands of birth control are safe and effective ``morning-after pills,'' the first federal acknowledgment of the emergency contraception that European women have been prescribed for years.
``The best-kept contraceptive secret is no longer a secret,'' said FDA Commissioner David Kessler. ``Women should have the information that this regimen is available.''
The decision opens the door for companies to specially package birth control pills for women to have on hand in case of an emergency, just as the pills are routinely sold overseas.
Contraceptive manufacturers so far have refused to sell what the government terms emergency contraception here, citing litigation and political fears.
So while it is legal for doctors to prescribe emergency birth control - and the American College of Obstetrics and Gynecology in December endorsed it - few physicians know the proper doses and few women even know to seek it.
The FDA's decision could change that. One small company, New Jersey-based Gynetics, is developing a specially packaged version of birth control that it hopes to sell for emergency use next year.
And the FDA's instructions were purposefully detailed enough to tell family-planning clinics and private doctors the right dose to hand to women today.
``This should be in everyone's medicine cabinet,'' said Janet Benshoof of the Center for Reproductive Law and Policy.
The FDA announced Monday that high doses of six popular birth-control brands, when taken within three days of unprotected sex, are 75 percent effective at preventing pregnancy.
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 if the women took emergency contraception, explained Dr. James Trussell of Princeton University.
His research convinced the FDA that emergency contraception could prevent up to 2.3 million unplanned pregnancies a year, 1 million of which now end in abortion.
``We're going to see a really big change here,'' said Trussell, who helped set up a hot line and Internet service that offers women information about emergency contraception and addresses of nearby doctors who already prescribe it.
He said women typically pay $21 for a cycle of birth control pills plus the cost of a doctor's visit.
To work, two to four birth control pills are taken anytime up to 72 hours after sex - not just the ``morning after'' - and then the same dose is taken again exactly 12 hours later. The brands include Wyeth-Ayerst Laboratories' Ovral, Lo/Ovral, Nordette and Triphasil, and Berlex Laboratories Levlen and Tri-Levlen.
The pills prevent a fertilized egg from implanting into the uterus so that it can grow into an embryo. If a woman already is pregnant, the pills will have no effect.
Emergency contraception is different from the controversial abortion pill RU-486, which is awaiting final FDA approval and ends pregnancy by expelling an already growing embryo from the uterus.
The emergency contraceptive's side effects are nausea and vomiting, sometimes severe enough to prevent the pills from working. Over 4 million women have taken emergency contraception in Britain alone, and studies there have shown no serious side effects.
The FDA stopped short of forcing Wyeth-Ayerst and Berlex to relabel their contraceptives to add the emergency use, deciding instead to take the information directly to consumers and physicians.
``We're outraged'' by the FDA action, said Judie Brown of the American Life League, which opposes any use of birth control pills but particularly objects to emergency birth control. ``Our concern is over the fate of the preborn child.''
For more information, call 800-584-9911 or check the Internet at http://opr.princeton.edu/ec/
LENGTH: Medium: 81 linesby CNB