ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Sunday, June 30, 1996 TAG: 9607010086
SECTION: NATIONAL/INTERNATIONAL PAGE: A-6 EDITION: METRO
DATELINE: CHICAGO
SOURCE: Chicago Tribune
MANY DOCTORS and most women are unaware of The Pill's potential for postcoital use because drug makers do not include that information on labels and package inserts.
An FDA advisory panel concluded unanimously Friday that certain widely available oral contraceptives are safe and effective when used as ``morning after'' pills.
The unusual action was intended to boost the availability of a method of emergency contraception that is not widely known and induce a pharmaceutical company to package and label the pills for this use - as is done in Britain, Germany, Sweden and more than 20 other countries.
``Normally, a drug company files a marketing application and we react,'' said Mary Pendergast, deputy commissioner of the Food and Drug Administration. ``But occasionally, in matters of importance, we do the work ourselves and publish it as our finding.''
The FDA almost always accepts the recommendations of its advisory committees.
Unlike RU-486, an abortifacient not yet approved for use in the United States, these pills are considered contraceptives by the medical community and are prescribed legally. But most women, and many doctors, are unaware of their potential for postcoital use because drug makers do not include that information on labels and package inserts.
Supporters say emergency contraceptive pills, or ECPs, could prevent 1.7 million unwanted pregnancies and 800,000 abortions a year in this country.
Friday's action capped a day of public testimony at a hearing of the FDA Advisory Committee for Reproductive Health Drugs.
The FDA had rejected a petition from a number of reproductive rights groups to force the manufacturers of six common birth control pills to relabel their products, an agency spokesman said, but it agreed to hold a public hearing to consider the data and issue a recommendation.
Elevated doses of oral contraceptives that combine an estrogen and a progestin have been known for more than 25 years to prevent pregnancy when taken within 72 hours after unprotected intercourse. On Friday, researcher James Trussell, director of the Office of Population Research at Princeton University, told the panel the window of effectiveness was probably longer than 72 hours.
Trussell said he looked at all 10 available studies ``in which you could compare the observed number of pregnancies with the expected number of pregnancies for that population.'' The conclusion: Emergency contraceptive pills reduce the risk of pregnancy by 75 percent.
As for safety, Dr. Elizabeth Barden of the British National Health Service testified that there had been only 115 reports of side effects and adverse reactions in the United Kingdom since 1985, including 61 pregnancies. She estimated that, in that time, 3.5 million doses had been administered.
The major side effects are nausea and vomiting. There have been six possible cases of serious adverse reactions, including one death, she said, but none of those was determined to be caused by the pills.
The FDA has let U.S. drug companies know it would welcome an application to market birth control pills as ECPs. But the companies are not biting.
In addition to fears of liability suits, drug companies are reluctant to risk negative publicity or a possible boycott by anti-abortion groups, which believe postcoital contraception is tantamount to chemical abortion.
LENGTH: Medium: 67 linesby CNB