FDA Approves Morning After Pill

The Food and Drug Administration Wednesday allowed the first-ever sales and marketing of a kit of emergency contraceptive pills that women can take the morning after unprotected sex to prevent pregnancy.

The PREVEN kits will be available by prescription by the end of September, said Roderick Mackenzie, chairman and founder of Gynetics Inc. of Somerville, N.J., which won the first approval to advertise and sell morning-after pills.

The FDA has long told women, and doctors, how to use standard birth control pills in this manner, and the agency last year gave out specific information about which pills and dosages were effective as contraception up to 72 hours after unprotected sex.

But Wednesday's approval, for the first time, allows a pharmaceutical company to advertise and to sell special morning-after packets that women can keep in their medicine cabinets.

"It's not only a scientific but an ethical advance," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "Women now have more options, and have long deserved to have the rights to prevent unplanned pregnancies."

Anti-abortion groups, however, have criticized the method.

The morning-after pills are different from RU-486, the French abortion pill, which actually ends a pregnancy several weeks after it has begun.

Gynetics had said the company would market the emergency kit last year, becoming the first U.S. company to take action since the FDA approved using contraceptive pills for emergency birth control.

In February 1997, the FDA said six brands of birth control pills were safe and effective as morning-after pills, the first federal acknowledgment of the emergency birth control method that European women have been prescribed for years.

Until now, however, contraceptive manufacturers have refused to sell the form of emergency birth control here, citing litigation and political fears.

The pills prevent or delay ovulation, experts said. Some say the pills could possibly prevent a fertilized egg from implanting in the uterine wall so it can grow into an embryo.

If an embryo is already implanted and growing, the morning-after pills will have no effect unlike with RU-486.

The FDA said the regimen is effective 75 percent of the time. It consists of taking two oral contraceptive pills within 72 hours of unprotected sex, and another two pills 12 hours later.

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 the emergency birth control, according to studies.

The emergency contraceptive's side effects are nausea and vomiting, sometimes severe. More than 4 million women have taken emergency contraception in Britain alone, and studies there have shown no serious side effects.

Written by Deepti Hajela