ADVERSE REACTIONS
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 (
5.2
)]
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 clinical practice.
In a 12-week, randomized, placebo-controlled trial of Evamist in 454 women, 80 to 90 percent of women randomized to active drug received at least 70 days of therapy and 75 to 85 percent randomized to placebo received at least 70 days of therapy.
The adverse reactions that occurred in at least 5 percent of women in any treatment group are shown in Table 1.
Table 1. Frequency of Adverse Reactions (≥ 5 Percent) in Any Treatment Group in a Controlled Study of Evamist
|
Frequency n (%)
|
System Organ Class
Preferred Term
|
1 Spray
|
2 Sprays
|
3 Sprays
|
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.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Evamist. 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.
Breasts: Breast swelling, breast mass, breast enlargement
Cardiovascular: Heart rate increased
Central nervous system: Dizziness, dysgeusia, paresthesia, lethargy, hypoesthesia
Eyes: Eye irritation, ocular hyperemia
Gastrointestinal: Abdominal pain, diarrhea, constipation, abdominal distension, dry mouth, decreased appetite
Genitourinary system: Vaginal bleeding
Musculoskeletal: Muscle spasms, arthritis
Psychiatric: Insomnia, mood swings, anxiety, irritability, mood altered, depression
Respiratory tract: Cough, dyspnea, dry throat
Skin: Nipple and areola discoloration, usually on the same side of the body as the inner forearm on which Evamist is applied, rash, pruritus, alopecia, urticaria, dry skin, skin discoloration, chloasma
Miscellaneous: Weight increased, malaise, fatigue, asthenia
|