"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.
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.
Table 7. ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS
OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH PREFEST (estradiol, norgestimate)
|FOUR 12-MONTH CLINICAL TRIALS|
| PREFEST (estradiol, norgestimate) (Estradiol and NGM)
(N = 579)
|Body as a Whole|
|Back pain||69 (12%)|
|Fatigue||32 ( 6%)|
|Influenza-like symptoms||64 (11%)|
|Pain||37 ( 6%)|
|Abdominal pain||70 (12%)|
|Flatulence<||29 ( 5%)|
|Nausea||34 ( 6%)|
|Tooth disorder||27 ( 5%)|
|Arthralgia||51 ( 9%)|
|Myalgia||30 ( 5%)|
|Breast pain||92 (16%)|
|Dysmenorrhea||48 ( 8%)|
|Vaginal bleeding (all)||52 ( 9%)|
|Vaginitis||42 ( 7%)|
|Resistance Mechanism Disorders|
|Viral infection||35 ( 6%)|
|Coughing||28 ( 5%)|
|Pharyngitis||38 ( 7%)|
|Sinusitis||44 ( 8%)|
|Upper respiratory-tract infection||121 (21%)|
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
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.
Retinal vascular thrombosis, intolerance to contact lenses.
Central nervous system
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the Prefest (estradiol, norgestimate) Side Effects Center for a complete guide to possible side effects »
Drug/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 antifactor 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-1-antitrypsin, ceruloplasmin).
- Increased plasma HDL and HDL2cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
- Impaired glucose tolerance.
- Reduced response to metyrapone test.
Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.
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