A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Vaniqua Side Effects, and Drug Interactions - Eflornithine
Vaniqua Side Effects, and Drug Interactions - Eflornithine
SIDE EFFECTS
Adverse events reported for most body systems occurred at similar frequencies
in VANIQA 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.
|
|
Vehicle-Controlled
Studies |
Vehicle-Controlled and
Open-Label Studies |
|
Adverse Event Term
|
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 (eflornithine hydrochloride)
Cream, 13.9%.
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.
DRUG INTERACTIONS
It is not known if VANIQA has any interaction with other topically applied
drug products.
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