ADVERSE REACTIONS
Adverse events reported for most body systems occurred at similar frequencies in VANIQA (eflornithine hydrochloride) Cream, 13.9% and vehicle control groups. The most frequent adverse events related to treatment with VANIQA were skin-related. The following table notes the percentage of adverse events associated with the use of VANIQA or its vehicle that occurred at greater than 1% in both the vehicle-controlled studies and the open-label safety studies up to 1 year of continuous use.
| Adverse Event Term |
Vehicle-Controlled Studies |
Vehicle-Controlled and Open-Label Studies |
VANIQA
(n=393) |
Vehicle
(n=201) |
VANIQA
(n=1373) |
|
Acne
|
21.3
|
21.4
|
10.8
|
|
Pseudofolliculitis Barbae
|
16.3
|
15.4
|
4.9
|
|
Stinging Skin
|
7.9
|
2.5
|
4.1
|
|
Headache
|
3.8
|
5.0
|
4.0
|
|
Burning Skin
|
4.3
|
2.0
|
3.5
|
|
Dry Skin
|
1.8
|
3.0
|
3.3
|
|
Pruritus (itching)
|
3.8
|
4.0
|
3.1
|
|
Erythema (redness)
|
1.3
|
0.0
|
2.5
|
|
Tingling Skin
|
3.6
|
1.5
|
2.2
|
|
Dyspepsia
|
2.5
|
2.0
|
1.9
|
|
Skin Irritation
|
1.0
|
1.0
|
1.8
|
|
Rash
|
2.8
|
0.0
|
1.5
|
|
Alopecia
|
1.5
|
2.5
|
1.3
|
|
Dizziness
|
1.5
|
1.5
|
1.3
|
|
Folliculitis
|
0.5
|
0.0
|
1.0
|
|
Hair Ingrown
|
0.3
|
2.0
|
0.9
|
|
Facial edema
|
0.3
|
3.0
|
0.7
|
|
Anorexia
|
1.0
|
2.0
|
0.7
|
|
Nausea
|
0.5
|
1.0
|
0.7
|
|
Asthenia
|
0.0
|
1.0
|
0.3
|
|
Vertigo
|
0.3
|
1.0
|
0.1
|
|
Treatment related skin adverse events that occurred in less than 1% of the subjects treated with VANIQA are: bleeding skin, cheilitis, contact dermatitis, swelling of lips, herpes simplex, numbness and rosacea.
Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of VANIQA. Only 2% of subjects discontinued studies due to an adverse event related to use of VANIQA.
LABORATORY TEST ABNORMALITIES
No laboratory test abnormalities have been consistently found to be associated with VANIQA. In an open labeled study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.
|
