ADVERSE REACTIONS
Clinical Study 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.
In a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80-90% of women randomized to active drug received at least 70 days of therapy and 75-85% randomized to placebo received at least 70 days of therapy.
The adverse reactions that occurred in at least 5% of women in any treatment group are shown in Table 1.
Table 1. Frequency of Adverse Reactions (≥ 5%) in Any Treatment Group in a Controlled Study of Evamist | | Frequency n (%) | |
| System Organ Class | 1 Spray | 2 Sprays | 3 Sprays |
| Preferred Term | Placebo
(N=77) | Evamist
(N=76) | Placebo
(N=76) | Evamist
(N=74) | Placebo
(N=75) | Evamist
(N=76) |
| Reproductive System and Breast Disorders |
| Breast tenderness | 0 (0) | 4 (5) | 4 (5) | 5 (7) | 0 (0) | 4 (5) |
| Nipple pain | 0 (0) | 2 (3) | 0 (0) | 5 (7) | 0 (0) | 1 (1) |
| Gastrointestinal Disorders |
| Nausea | 5 (7) | 1 (1) | 1 (1) | 2 (3) | 4 (5) | 2 (3) |
| Infections and Infestations |
| Nasopharyngitis | 1 (1) | 4 (5) | 2 (3) | 3 (4) | 1 (1) | 1 (1) |
| Musculoskeletal and Connective Tissue Disorders |
| Back pain | 1 (1) | 2 (3) | 2 (3) | 4 (5) | 1 (1) | 2 (3) |
| Arthralgia | 1 (1) | 1 (1) | 4 (5) | 1 (1) | 0 (0) | 3 (4) |
| Nervous system |
| Headache | 4 (5) | 7 (9) | 5 (7) | 9 (12) | 7 (9) | 8 (11) |
Application site reactions were reported in 3 out of 226 (1.3%) women treated with Evamist.
Additional Adverse Reactions Reported With Estrogen and/or Progestin Therapy.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
Genitourinary System
Abnormal uterine bleeding/spotting, dysmenorrhea/pelvic pain, 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.
Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.
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.
Skin
Chloasma or melasma, that 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, exacerbation of chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia.
Miscellaneous
Increase or decrease in weight, glucose intolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, angioedema, anaphylactoid/anaphylactic reactions, hypocalcemia (preexisting condition), exacerbation of asthma, increased triglycerides.
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REPORTS OF SUSPECTED EVAMIST SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Evamist. The information is not vetted and should not be considered as verified clinical evidence.
Possible Evamist side effects / adverse reactions in 53 year old female
Reported by a consumer/non-health professional from United States on 2011-10-17
Patient: 53 year old female weighing 70.3 kg (154.7 pounds)
Reactions: Alopecia, Accidental Exposure
Suspect drug(s):
Evamist
Possible Evamist side effects / adverse reactions in 50 year old female
Reported by a individual with unspecified qualification from United States on 2012-02-29
Patient: 50 year old female
Reactions: Abdominal Pain, Respiratory Disorder, Cerebral Disorder, Blood Lactate Dehydrogenase Increased, Unresponsive TO Stimuli, Continuous Haemodiafiltration, Mental Status Changes, Convulsion, Malaise, Aspartate Aminotransferase Increased, Diarrhoea Haemorrhagic, Colitis, Haemolytic Uraemic Syndrome, Thrombocytopenia, Microangiopathy, Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Etanercept (Etanercept)
Indication: Rheumatoid Arthritis
Evamist
Dosage: transdermal
Indication: Product Used FOR Unknown Indication
Possible Evamist side effects / adverse reactions in 50 year old female
Reported by a individual with unspecified qualification from United States on 2012-06-07
Patient: 50 year old female weighing 59.0 kg (129.7 pounds)
Reactions: Treatment Noncompliance, Exposure VIA Direct Contact, Accidental Exposure
Adverse event resulted in: disablity
Suspect drug(s):
Evamist
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