WASHINGTON, March 30 (UPI) -- The U.S. Food and Drug Administration approved Quartette -- levonorgestrel/ethinyl estradiol and ethinyl estradiol -- tablets to prevent pregnancy.
Dr. James A. Simon, clinical professor of obstetrics and gynecology at the George Washington University School of Medicine, said Quartette -- produced by Teva Pharmaceutical Industries Ltd. in Israel -- represents the next generation of extended regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.
"Breakthrough bleeding can be experienced with any birth control pill, especially during the first few months, and is one of the reasons a large number of women discontinue extended regimens," Simon said in a statement. "The estrogen in Quartette increases at specific points and provides four short light periods a year. Breakthrough bleeding decreases over time, which might help encourage patient adherence."
The approval was based on a development program that included results from Phase I, Phase II and Phase III clinical trials designed to evaluate the safety and efficacy of Quartette. The Phase III clinical trial, which involved more than 3,000 women, found Quartette was 97 percent effective at preventing pregnancy.
Quartette features a unique 91-day oral regimen, the dose of estrogen increases at three distinct points over the first 84 days and the amount of progestin remains consistent; this is followed by seven days of 10 micrograms of ethinyl estradiol.
However, Quartette is not recommended for women, who smoke cigarettes and are age 35 and older. Smoking increases risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes smoked, Teva said.
The use of hormonal birth control is associated with increased risk of several serious side effects, including blood clots, stroke, and heart attack, the company said.