FDA approves drug for older women experiencing painful sex

FDA approves drug for older women experiencing painful sex
Osphena taken for 12 weeks found safe, effective in reducing discomfort.

(HealthDay)—The U.S. Food and Drug Administration has approved a new drug to treat postmenopausal women who experience pain during sex, the agency announced Tuesday.

The drug Osphena (ospemifene) mimics the effects of estrogen on vaginal tissue, which can become thinner, drier and more fragile from menopause. The pill, taken with food once a day, makes vaginal tissue thicker and less fragile to reduce pain during sex (called dyspareunia).

"Dyspareunia is among the problems most frequently reported by ," said Dr. Victoria Kusiak, deputy director of the Office of III in the FDA's Center for Drug Evaluation and Research, in an FDA news release. "Osphena provides an additional treatment option for women seeking relief."

The safety and effectiveness of Osphena was established in three clinical studies involving nearly 1,900 postmenopausal women with signs of vulvar and vaginal atrophy, or thinning and fragile vaginal tissue.

Women were randomly assigned take either Osphena or a placebo. In the first two studies, those who took the drug for 12 weeks experienced significantly less pain during sex than the women in the .

Although a third study on Osphena found the drug is safe for long-term use, the FDA noted that the drug should be prescribed for the shortest duration needed.

Osphena can cause the to thicken, which is abnormal for postmenopausal women, the FDA cautioned. Women should seek medical attention right away if they experience unusual bleeding since it could be a warning sign of uterine cancer.

The new drug can also increase women's risk for stroke and , but not as much as estrogen-alone therapy, the FDA advised. Other possible Osphena side effects include hot flashes, vaginal discharge, muscle spasms, genital discharge and excessive sweating.

More information: The International Society for Gynecologic Endoscopy has more about pain during sex.

add to favorites email to friend print save as pdf

Related Stories

FDA OKs Amitiza for treatment of IBS-C

Apr 30, 2008

The U.S. Food and Drug Administration announced approval of Amitiza (lubiprostone) to treat constipation associated with irritable bowel syndrome.

Generic boniva approved for osteoporosis

Mar 19, 2012

(HealthDay) -- The first generic versions of the once-monthly osteoporosis drug Boniva (ibandronate) have been approved by the U.S. Food and Drug Administration.

Recommended for you

Xtoro approved for swimmer's ear

18 hours ago

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

19 hours ago

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

Judge halts Alzheimer's drug swap until July

Dec 16, 2014

A federal judge has ordered an Irish drug manufacturer to halt its plans to discontinue its widely used Alzheimer's medication, allegedly in an effort to drive patients to a newer patented drug.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.