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February 9, 2010
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Medications and Drugs

GENERIC NAME: eflornithine

BRAND NAME: Vaniqa

DRUG CLASS AND MECHANISM: Eflornithine is the first topical drug for the treatment of unwanted facial and chin hair. It does not remove the hair but rather slows its growth. The cells surrounding the base of each hair (called the hair follicle) undergo rapid growth and maturation as they transform into hairs. Certain proteins called polyamines are needed for this rapid cell growth and differentiation, and the production of these polyamines depends on the activity of an enzyme, ornithine decarboxylase (ODC). Eflornithine is believed to block ODC and thereby slow the growth and differentiation of the cells within the hair follicles. Almost 600 patients were studied who routinely had to remove facial hair at least twice weekly and had more than 5 hairs per square centimeter of skin. The re-growth of hair was evaluated 48 hours after patients shaved before, during, and at the end of treatment. The patients received either eflornithine cream or a placebo cream twice daily for 24 weeks. By the end of 24 weeks of treatment, 70% of eflornithine-treated patients had at least some reduction in the rate of hair growth compared with 41% of placebo-treated patients. Moreover, 35% of eflornithine-treated patients had a marked reduction in the rate of growth (only minimal darkening of facial skin due to re-growth of hair) compared to 9% of placebo-treated patients." Eflornithine was approved by the FDA in July 2000.

GENERIC AVAILABLE: no

PRESCRIPTION: yes

PREPARATIONS: Eflornithine is available as a 30 gram tube of cream at a concentration of 13.9 %.

STORAGE: Eflornithine should be stored at room temperature, 15-30°C(59-86°F) and should not be frozen.

PRESCRIBED FOR: Eflornithine is used to slow hair growth on the face and chin in women ages 12 and older.

DOSING: Eflornithine should be applied in a thin layer around the affected facial areas and chin and rubbed-in thoroughly. It is applied twice daily with at least eight hours between applications or as directed by a physician. Eflornithine should not be washed away from the skin for at least eight hours after application. Cosmetics and sunscreens may be applied once the treated area has dried. Hair removal techniques such as tweezing should be continued.

DRUG INTERACTIONS: No studies have been done to determine if eflornithine interacts with other drugs applied to the skin.

PREGNANCY: There have been no studies of eflornithine therapy in pregnant women.

NURSING MOTHERS: It is not known if eflornithine is secreted into breast milk.

SIDE EFFECTS: The most common side effects seen with eflornithine are acne, swollen patches that are sometimes reddened and contain a buried hair (pseudofolliculitis barbae), headache , skin itching, burning or tingling, rash, and ingrown hairs. Less common side effects are bleeding skin, swollen lips, nausea, numbness, contact dermatitis, and herpes simplex.

Reference: FDA Prescribing Information


Last Editorial Review: 12/14/2000 9:45:00 AM




Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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eflornithine, Vaniqa

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An ingrown hair happens when the sharp tip of the hair curls back or grows sideways into the skin. It is a benign condition, which usually appears as a small tan or sometimes pink bump under the skin. Often, a small pinpoint (often dark) part of the underlying hair may be seen under the skin bump. In more extensive cases, multiple small red or pink little bumps around hair follicles may be seen on any skin area that has been frequently shaved, such as face, neck, armpits, legs, and pubic region.

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