FDA Approves New Birth Control Pill
May 14, 2001 -- Berlex Laboratories announced today that the FDA approved its new oral contraceptive called Yasmin . The low-dose pill touts a different form of the hormone progestin called drospirenone, which the company claims is unique to this birth control pill.
In a prepared statement, Berlex noted the contraceptive has been available in Europe since November 2000, where it is being used by more than 500,000 women.
Because its different form of progestin is a relative of the long-used diuretic called spironolactone, the company warned the new contraceptive is not appropriate for women with diseases of the kidney, liver, or adrenal glands. By changing the body's balance of water and nutrients, the substance can increase potassium levels, which could lead to heart problems and other health concerns.
The company added that its clinical trials showed Yasmin is more than 99% effective in preventing pregnancy, and only 6% of the women using it stopped because of side effects.
Birth control pills are the multitasking drugs of the new millennium. Once used only for contraception, the drugs are now used to treat conditions ranging from headache to acne.
Recently, researchers have been testing the role of drospirenone in treating premenstrual syndrome. Earlier this month, Candace Brown, PharmD, of the University of Tennessee in Knoxville, told WebMD that women who take Yasmin don't experience weight gain and are less likely to experience moodiness and irritability before and during their menstrual cycles.
Brown, who holds joint appointments as a professor of pharmacy practice, obstetrics and gynecology, and psychiatry, presented findings at a recent meeting of the American College of Obstetricians and Gynecologists from a study of 258 women who took the pill.
In the study, the women knew they were taking Yasmin and were asked to fill in diaries about their premenstrual symptoms after they completed six months on the pill. Brown said the study design is "not well controlled, so we will need to wait for results of a well-planned, placebo-controlled trial to verify the findings."
Nonetheless, she said that the results of this trial were very encouraging because the women "had marked changes in their responses to the Menstrual Distress Questionnaire." After six months, the women said they felt better and had less water retention than before they took the pill, she said.
Brown said there are probably several explanations for these positive findings. First, the new pill has what's called a monophasic design, meaning that it releases the same dose of the hormones in each dose.
"Other pills vary the dose during the cycle, and I think they may not be as effective in controlling moodiness," she said.
At the time, Brown had told WebMD she expected the FDA to approve Yasmin as a contraceptive sometime this summer. Once that happened, she said, Berlex would try to win approval for using it as a treatment for PMS.