"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
- Patient Information:
Details with Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
Divigel® was studied at doses of 0.25, 0.5 and 1.0 g/day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5% Caucasian). The adverse events that occurred at a rate greater than 5% in any of the treatment groups are summarized in Table 5.
Table 5: Number (%) of Subjects with Common Adverse
Events* in a 12-Week Placebo- Controlled Study of Divigel®
|SYSTEM ORGAN CLASS Preferred Term||Divigel®||Placebo
|INFECTIONS & INFESTATIONS|
|Nasopharyngitis||7 (5.7)||5 (4.1)||6 (4.8)||5 (4.0)|
|Upper Respiratory Tract Infection||7 (5.7)||3 (2.4)||2 (1.6)||2 (1.6)|
|Vaginal mycosis||1 (0.8)||3 (2.4)||8 (6.4)||4(3.2)|
|REPRODUCTIVE SYSTEM & BREAST DISORDERS|
|Breast Tenderness||3 (2.5)||7 (5.7)||11 (8.8)||2 (1.6)|
|Metrorrhagia||5 (4.1)||7 (5.7)||12 (9.6)||2 (1.6)|
|* Adverse events reported by ≥5% of patients in any treatment group.|
In a 12-week placebo-controlled study of Divigel®, application site reactions were seen in <1% of subjects.
- Genitourinary system: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; vaginal discharge.
- Breasts: Tenderness; enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes; breast cancer; nipple pain.
- Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
- Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas; abdominal pain.
- Skin: Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash.
- Eyes: Retinal vascular thrombosis, intolerance to contact lenses.
- Central Nervous System: Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
- Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; muscle cramps.
Read the Divigel (estradiol gel) Side Effects Center for a complete guide to possible side effects
Drug and Laboratory Test Interactions
- Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
- Increased thyroid binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
- Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-l-antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Last reviewed on RxList: 6/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Divigel Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.