"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
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|
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-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.
Read the Vaniqa (eflornithine) Side Effects Center for a complete guide to possible side effects
Last reviewed on RxList: 3/9/2016
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