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WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) and Clinical Studies (14.5, 14.6)].Â
The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (
5.1)Â and Clinical Studies ].Â
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies].
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].Â
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3) and Clinical Studies (14.5, 14.6)].
The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (
5.1) and Clinical Studies (14.5)].Â
The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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FEMHRT SUMMARY
femhrt ® (norethindrone acetate/ethinyl estradiol tablets) is a continuous dosage regimen of a progestin-estrogen combination for oral administration. The following two strengths of femhrt tablets are available: femhrt (0.5 mg/2.5 mcg): Each white oval tablet contains 0.5 mg norethindrone acetate and 2.5 mcg ethinyl estradiol. femhrt (1 mg/5 mcg): Each white D-shaped tablet contains 1 mg norethindrone acetate and 5 mcg ethinyl estradiol.
femhrt is indicated in women with an intact uterus for the:
- Treatment of moderate to severe vasomotor symptoms associated with the menopause.
- Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis. Non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown a risk ratio of about 0.4 for hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause, compared to women taking calcium and vitamin D alone. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen reduces further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
Data from the Women's Health Initiative study showed that use of estrogen-plus-progestin (dose equivalent to 0.625 mg CE and 2.5 mg MPA) resulted in about 5 less hip fractures per 10,000 women-years, compared to use of placebo (risk ratio about 0.66).
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NEWS HIGHLIGHTSMedia Articles Related to Femhrt (Norethindrone / Ethinyl Estradiol)
6 in 10 of America's Single Guys 'Take Responsibility' for Contraception
Source: MedicineNet Vasectomy Specialty [2017.08.31]
Title: 6 in 10 of America's Single Guys 'Take Responsibility' for Contraception
Category: Health News
Created: 8/31/2017 12:00:00 AM
Last Editorial Review: 8/31/2017 12:00:00 AM
Clinical Trials Related to Femhrt (Norethindrone / Ethinyl Estradiol)
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone [Completed]
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
Study of Loestrin 24(24 Days of "Real" Pills) Fe Versus Loestrin 1/20 (21 "Real" Pills) [Completed]
The purpose of this research study is to assess hormone withdrawal symptoms in women while
taking an oral contraceptive in the novel 24/4 (24 days of "real" pills) manner in
comparison to taking pills in the standard 21/7 (21 "real" pills) manner.
It is hypothesized that the 24/4 method will reduce common hormone withdrawal symptoms
compared to the standard 21/7 regimen.
It is further hypothesized that women using the 24/4 regimen will report greater
satisfaction scores.
Gender Disparity and Hormones in Cystic Fibrosis [Recruiting]
The objective of this study is to investigate the impact of hormones on lung disease in
Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and
healthier lives than they did 20 years ago. However, females have been shown to have a
survival disadvantage. The median life expectancy is 33 in women and 37 in men with CF. The
hypothesis is that estrogen and/or progesterone negatively impact lung health in CF.
Therefore, understanding the impact of sex hormones (including the use of birth control
pills) on the disease process is increasingly important. The purpose of this study is to
determine if lung function, respiratory symptoms, or various markers of lung health change
during different phases of the natural ovulatory cycle in order to understand if estrogen or
progesterone hormones are impacting the disease relative to fluctuations in men with stable
testosterone levels. The research objectives of this project are to:
- Determine if lung function, respiratory symptoms, or various markers of lung health
change during different hormonal phases of the ovulatory cycle in women.
- Determine if men change lung function, respiratory symptoms, or various markers of lung
health over time.
- Determine if oral contraceptive pills in women stabilize fluctuations in symptoms and
improve lung health.
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions [Completed]
The purpose of this study was to evaluate the relative bioavailability of a test formulation
of norethindrone/ethinyl estradiol 0. 4 mg/0. 035 mg chewable tablets (Teva Pharmaceuticals,
USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol
and ferrous fumarate) 0. 4 mg/0. 035 mg Chewable tablets (Warner Chilcott) under fed
conditions in healthy, non-tobacco using, adult female subjects.
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis [Completed]
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on
the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female
patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child
bearing age. The RA patients received OC in combination with TCZ, whereas the healthy
volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8
mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The
healthy volunteers received OC for only one 21-day cycle.
Reports of Suspected Femhrt (Norethindrone / Ethinyl Estradiol) Side Effects
Hypertension (5),
Contusion (3),
Fall (3),
Femur Fracture (2),
Drug Interaction (2),
Cyst (2),
Limb Crushing Injury (2),
Speech Disorder (2),
Balance Disorder (2),
Palpitations (2), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Femhrt has an overall score of 7.50. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Femhrt review by 58 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | .5 mg taken once daily for the period of 5 years |
| Other conditions: | | osteopenia |
| Other drugs taken: | | fosomex | | |
Reported Results |
| Benefits: | | I have been taking this treatment for 4 years and the goal is to prevent any more bone loss and possibly to improve it. Combined with weight bearing exercise supposedly my bone loss will change. I had a test a year after I started taking fosamex and there was slight improvement; I have not had another test since. I will be due for a test my next annual obg visit. |
| Side effects: | | none |
| Comments: | | once a week with water no food,drink or reclining for 30 minutes |
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| | Femhrt review by 49 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | 1 mg/5mcg taken 1x daily for the period of 2 mos. |
| Other conditions: | | hypothyroid disease |
| Other drugs taken: | | synthryoid | | |
Reported Results |
| Benefits: | | reduced hot flashes; reduced heart palpitations |
| Side effects: | | mood swings; not enough estrogen |
| Comments: | | I started taking the drug 2 months ago to streamline a regime that consisted of taking estrodial and a progestrene cream. So far, I feel it doesn't have enough estrogen to regulate mood swings and dryness of skin. I also have breast tenderness and continued heart palpitations. I think I prefer going back to activella along with the progestrone cream. |
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Page last updated: 2017-08-31
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