Yaz Approved for Severe PMS

Oct. 6, 2006 -- Yaz has become the first birth control pill to gain FDA approval for treating premenstrual dysphoric disorder (PMDD), the most severe form of PMS.

The FDA based its action on clinical trial results showing that Yaz cut PMDD symptoms by at least half. Women taking Yaz reported twice as much improvement in PMDD symptoms as women taking inactive placebo pills.

Yaz improved both physical and emotional symptoms of PMDD, including interpersonal relationships, work productivity, and enjoyment of hobbies and social activities.

Like other birth control pills, Yaz uses the female hormones estrogen and progestin. Unlike other versions of the pill, Yaz uses a form of progestin that has unique properties. This, plus its 24-day dosing regimen, may help account for its positive effect on PMDD, says Andrea Rapkin, MD, in a news release from Berlex Inc., the U.S. affiliate of Schering that manufactures Yaz.

"For my PMDD patients who need a treatment to reduce their symptoms -- as well as a safe and effective contraceptioncontraception to prevent pregnancypregnancy -- YAZ is an important option that can meet both of their health care needs in a single pill," says Rapkin, professor of obstetrics and gynecology at UCLA's David Geffen School of Medicine.

While most women have some PMS symptoms, PMDD occurs when these symptoms are at their most severe. PMDD affects about 5% of women.

PMDD: PMS Squared

Think of PMDD as PMS squared. Women with PMDD have at least five severe premenstrual symptoms. These may include:

• Feelings of sadness, hopelessness, or worthlessness
• Anxiety or tension
• Unstable mood and frequent crying
• Persistent irritability causing conflict in relationships
• Loss of interest in usual activities or relationships
• Lack of concentration
• Lack of energy
• Changes in appetite, possibly including cravings or binge eating
• Sleeping too much or too little
• Feeling out of control
• Physical symptoms including breast tenderness, breast swelling, headache, joint/muscle aches, bloating, and weight gain.

At least one of the first four symptoms must be present for a diagnosis of PMDD. The symptoms occur during the week before a woman's period and resolve within a few days after her period starts.

Because PMDD is so severe, doctors usually prescribe antidepressants, antianxiety medications, hormonal treatments, and/or water pills. While doctors have used other oral contraceptives as treatments for PMDD, Yaz is the first drug of this class to receive specific FDA approval for this purpose.

The most common side effects seen in women taking Yaz are headache and breast pain.