How safe is Osphena®?
Osphena® is the only oral, hormone-free treatment for moderate to severe painful sex due to menopause.
Osphena® was approved by the FDA in 2013 and has safety and efficacy data from one of the largest clinical programs of post-menopausal women with dyspareunia.
Osphena® is used after menopause for women with or without a uterus to treat moderate to severe pain during sexual intercourse due to changes in and around your vagina.
The effectiveness and safety of Osphena® on moderate to severe symptoms of vulvar and vaginal atrophy in post-menopausal women were established through three placebo controlled clinical trials of up to 52 weeks (long-term safety study) with over 1,900 post-menopausal women studied.
Osphena’s post approval experience is identified through voluntary reports and information monitoring. In February 2015, the product information was expanded to include allergic conditions including hypersensitivity. No further adverse event information has required label changes/additions.
- Based on its safety and efficacy profile, Osphena® is designated as Level A treatment recommendation from two pivotal medical organizations in women’s health (American College of Obstetricians and Gynecologists and North American Menopause Society).
- Discontinuation rates with Osphena® due to hot flash were less than 1%.
- No clinically significant breast changes in patients treated with Osphena® have been reported.
- In clinical trials, less than 1% of patients experienced treatment related cardiovascular events.
- There were no cases of endometrial cancer reported in our clinical trials.
- No dose adjustments are necessary for patients with mild, moderate or severe kidney impairment.
- No dose adjustments are necessary for patients with mild or moderate liver impairment.
- Osphena® has not been studied in patients with severe liver impairment, therefore it cannot be recommended for use in those patients
The most important information you should know:
- Osphena® carries a Boxed Warning for Endometrial Cancer and Cardiovascular Disorders.
- The most common side effects are (≥1 percent) include hot flash, vaginal/genital discharge, muscle spasms & excessive sweating.
Before taking Osphena®, consult your doctor if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
- Currently have or have had blood clots
- Had a stroke or heart attack
- Are allergic to Osphena® or any of its ingredients
- Think you may be pregnant
Talk to your healthcare provider every 3 to 6 months about whether you need to continue treatment with Osphena®
Learn more about How Osphena Helps treat moderate to severe painful sex due to menopause.