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Morning-After Contraceptive Given Government Approval

By John Schwartz
The Washington Post

For the first time, the Food and Drug Administration has given the government's formal endorsement to using high doses of birth control pills as an emergency contraceptive.

The agency Monday took the unusual step of inviting drug companies that make oral contraceptives to apply for permission to market pills specifically packaged as "morning-after" contraception - which actually can be taken as long as 72 hours after intercourse.

The FDA took the action to publicize a contraceptive method that has been known to be safe and effective since the 1970s and is widely used in Europe.

While many U.S. doctors are familiar with the approach and could legally prescribe it, some have been reluctant to use the method without formal government approval. And many women have not known about it.

"The best-kept contraceptive secret is no longer a secret," said FDA Commissioner David A. Kessler in announcing the move.

While family planning proponents hailed the action, a representative of a prominent anti-abortion group denounced the move as promoting abortion.

"For pro-lifers in general, we believe that life begins at conception and that means this, technically, is an abortifacient," said Gracie Hsu of the Family Research Council.

FDA officials said that the approach does not induce abortion, since most medical authorities agree that pregnancy begins at the time the fertilized egg becomes implanted in the uterus. High doses of birth control pills prevent ovulation, fertilization and implantation of the egg in the uterus. If the embryo has already become implanted in the uterine wall, the drugs will not cause an abortion.

The FDA action is aimed at making the method more readily available to women who have failed to use contraception, who believe their contraception methods may have been ineffective, or who have been raped, said Jacqueline Darroch Forrest of the Alan Guttmacher Institute, a family planning group in New York. "This gives you something to do instead of waiting around and seeing whether you got pregnant and having to decide whether you want to have an abortion or not."

Morning-after packages are sold in other countries, including Great Britain and the Netherlands, and could provide part of the explanation for the lower rates of abortion in those countries, Forrest said.

Monday's action does not involve the drug RU 486 (mifepristone), the so-called "abortion pill"; instead, it applies to contraceptives that include the drugs ethinyl estradiol, norgestrel, and levonorgestrel - forms of the hormones estrogen and progesterone that can prevent pregnancy by influencing a woman's menstrual cycle.

As an emergency contraceptive, the FDA said four combinations of these drugs can be taken any time within 72 hours after unprotected sex, with a second dose following 12 hours after. Common side effects include nausea, and about 20 percent of women taking the treatment vomit.

Birth control pills currently on the market could be used for emergency contraception, but their packaging can make it confusing. Some contain pills of two or more different colors, and some are placebos with no physiological effect. So the FDA Monday published the four regimens for the six contraceptive pills on the market containing the right drugs.

The FDA cautioned, however, that emergency contraception is not as effective as other methods of pregnancy prevention, only working about 74 percent of the time. Because not every act of unprotected sex leads to pregnancy, out of 100 women having intercourse without contraceptives in the second or third week of their menstrual cycle, about eight will become pregnant. If those 100 women take the morning-after treatment, only two will become pregnant, according to the FDA.

Oral contraceptives do not provide protection against sexually transmitted diseases such as AIDS, and so the FDA notice also includes a warning to "use condoms every time you have sex if you think you may be at risk."

The agency did not require manufacturers to make the labeling change, or order them to produce special "morning-after" packages, as some family planning advocates had wanted.

The largest manufacturers of contraceptives have told the FDA that they are not interested in repackaging their products for morning-after use.