"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.
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
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.
Adverse reactions reported by ≥ 5 percent of subjects in controlled clinical studies of femhrt are shown in Table 1.
Table 1: Associated Adverse
Reactions Reported by ≥ 5 Percent of Subjects by Body Systema
|BODY SYSTEM/Adverse Reaction||Placebo
N = 247
|Number (Percent) of Subjects|
N = 244
N = 258
|BODY AS A WHOLE||23 (12.8)||30 (16.9)||30 (15.7)|
|Edema - Generalized||10 (4.0)||12 (4.9)||11 (4.3)|
|Headache||12 (4.9)||14 (5.7)||16 (6.2)|
|DIGESTIVE SYSTEM||8 (4.4)||17 (9.6)||25 (13.1)|
|Abdominal Pain||3 (1.2)||13 (5.3)||14 (6.8)|
|UROGENITAL SYSTEM||20 (11.1)||34 (19.2)||45 (23.6)|
|Breast Pain||9 (3.6)||22 (9.0)||20 (7.8)|
|aThe total number of subjects for each body system may be less than the number of subjects with AEs in that body system because a subject may have had more than one AE per body system|
The following additional adverse reactions have been identified during post-approval use of femhrt. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; 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; uterine cancer; vaginal hemorrhage; ovarian cyst; irregular menstruation; metrorrhagia; menorrhagia; dysmenorrhea; uterine enlargement.
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; thrombosis; chest pain; myocardial infarction; cerebrovascular accident (stroke); transient ischemic attack; hemiparesis; increase in blood pressure; irregular heart rate; palpitations; dyspnea.
Nausea, vomiting; cholestatic jaundice; pancreatitis, enlargement of hepatic hemangiomas; bloating, abdominal cramps; abdominal pain; increased incidence of gallbladder disease; cholecystitis; cholelithiasis.
Retinal vascular thrombosis; visual impairment; intolerance to contact lenses.
Central Nervous System (CNS)
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; back pain; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; blood glucose abnormal; fatigue; myalgia; hypersensitivity.
Read the Femhrt (norethindrone acetate, ethinyl estradiol) Side Effects Center for a complete guide to possible side effects
No drug-drug interaction studies have been conducted for femhrt.
Effect Of Other Drugs On Combined Hormonal Products
Substances decreasing or increasing the plasma concentration of estrogen: In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects. Co-administration of atorvastatin and certain hormonal products containing ethinyl estradiol increase AUC values for ethinyl estradiol approximately 20 percent. Ascorbic acid and acetaminophen may increase the plasma ethinyl estradiol concentration, possibly by inhibition of conjugation.
Effect Of Combined Hormonal Products On Other Drugs
Combination hormonal products containing some synthetic estrogens (for example, ethinyl estradiol) may inhibit the metabolism of other compounds. Combination hormonal products have been shown to significantly decrease the plasma concentration of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/31/2014
Additional Femhrt 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.