Navigation Links
FDA Approves Drug for Older Women Experiencing Painful Sex
Date:2/26/2013

TUESDAY, Feb. 26 (HealthDay News) -- 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 postmenopausal women," said Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation 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 placebo group.

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 lining of the uterus 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 deep vein thrombosis, 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.

-- Mary Elizabeth Dallas

SOURCE: U.S. Food and Drug Administration, news release, Feb. 26, 2013


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Bionic Eye to Help Against Rare Vision Disorder
2. MSSD Approves of the Encinitas School District’s Holistic Education
3. FDA Approves 3 New Drugs for Type 2 Diabetes
4. FDA Approves 1st Skin Patch to Combat Migraines
5. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
6. FDA Approves New Type of Flu Vaccine
7. FDA Approves New Once-a-Day HIV Pill
8. FDA Approves Flu Vaccine for Coming Season
9. FDA Approves 2nd New Weight-Loss Drug
10. FDA Approves 1st Pill to Help Prevent HIV Infection
11. FDA Approves First New Weight-Loss Drug in More Than a Decade
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves Drug for Older Women Experiencing Painful Sex
(Date:6/24/2017)... ... June 24, 2017 , ... The Pennsylvania Athletic Trainers’ ... Bayfront and Erie Convention Center on June 8-10. The weekend consisted of ... bowl, award and scholarship presentations, and professional networking. , On Friday June ...
(Date:6/24/2017)... , ... June 24, 2017 , ... The weather is ... time outdoors. Home and business owners should be aware that the summer months provide ... In fact, mechanical locks and keys can be negatively affected from direct exposure to ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Rhode Island ... Care Management Alerts and Dashboards, an innovative new service enabling healthcare providers to ... Care Management Alerts and Dashboards provide near real-time data about patients admitted to ...
(Date:6/23/2017)... ... June 23, 2017 , ... By scoring 100% for fiscal ... four-star rating from premier online charity evaluator, Charity Navigator, validating ANRF's work as a ... all charities reviewed by Charity Navigator and earns ANRF a spot on their “ ...
(Date:6/23/2017)... ... June 24, 2017 , ... Studies show evidence that ... the risk of visual loss in these patients. , But how often do ophthalmologists ... smoking cessation to patients at risk of or with early symptoms of AMD? A ...
Breaking Medicine News(10 mins):
(Date:6/2/2017)... , June 2, 2017  NxStage Medical, Inc. (Nasdaq: ... care, today announced new findings demonstrating positive biochemical outcomes ... System One™. The data will be presented at ... Madrid, Spain . ... Improve Home Dialysis Network in Europe ...
(Date:5/30/2017)... AVIV, Israel , May 30, 2017 ... stage pharmaceutical Company specializing in the development of ... will present a company overview at three upcoming ... The 7th Annual LD Micro Invitational: ... Date:                     ...
(Date:5/24/2017)... May 24, 2017  ivWatch LLC today announced ... (OEM) Board to enable seamless integration of ivWatch,s ... systems, infusion pumps and other devices. By integrating ... able to help health care customers deliver a ... related to IV therapy. "The ivWatch ...
Breaking Medicine Technology: