HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, May 25, 2007

FDA Approves new "No-Period" Contraceptive Pill

Earlier this week, the Food and Drug Administration (FDA) approved Lybrel, a pill that stops a woman from having her period indeflintely.  The New York Times reports,   

The first birth-control pill meant to put a stop to a woman’s monthly period indefinitely has won federal approval, the manufacturer said on Tuesday.  When taken daily, the pill, called Lybrel and made by Wyeth, can halt women’s menstrual periods indefinitely and prevent pregnancies.

It is the latest oral contraceptive approved by the Food and Drug Administration to depart from the 21-days-on, 7-days-off regimen that had been standard since birth-control pill sales began in the 1960s, and is the first made to put off periods altogether when taken without a break.

Wyeth, based in Madison, N.J., plans to start Lybrel sales in July. The company said it had not determined a price. The pill contains a low dose of two hormones already widely used in birth-control pills, ethinyl estradiol and levonorgestrel.

There has been some mixed responses to this approval, some responses appearing quite odd to me.  Here is one reaction by Ms. Unruh, president of the National Abstinence Clearinghouse, as well as some responses by other bloggers.  I must admit, my reaction was -- how safe is this new drug?  -- The same response that I would have for any drug approved by the current FDA.  I also wonder if insurance companies plan to cover Lybrel.

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