Vaniqa FDA data, 2000  Title: FDA submission
Authors: Manufacturer
Journal:
PMID:
Affiliated institution: Bristol-Meyers
Squibb/Gillette
Cited in: Prescription insert at
www.vaniqa.com
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. 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:
| Adverse Event |
VANIQA |
Vehicle |
VANIQA |
| |
(n=393) |
(n=201) |
(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 |
|
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