FDA approves Shionogi's drug for painful sex in women

WASHINGTON (Reuters) - Health regulators said on Tuesday they have approved a drug made by Japan's Shionogi & Co to treat women experiencing pain during sexual intercourse.

The U.S. Food and Drug Administration approved the drug, Osphena, for a type of pain known as dyspareunia, which is a symptom of vulvar and vaginal atrophy due to menopause.

Dyspareunia is associated with declining levels of estrogen hormones during menopause. Osphena, known chemically as ospemifene, is a pill that acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in pain associated with intercourse.

The drug's label includes a boxed warning, the most severe available, alerting patients to an increased risk of strokes and deep vein thrombosis. Common side effects include hot flashes, vaginal discharge, muscle spasms and excessive sweating.

(Reporting By Toni Clarke; Editing by Gerald E. McCormick)