New Prescription Product Takes Aim at Facial Hair - Vaniqa
Drug Topics
September 4, 2000
For the female population, there's probably nothing more embarrassing than excess hair--just about anywhere. In hopes of removing these cosmetically unappealing strands, women have faithfully plucked, shaved, waxed, burned, electrocuted, and lasered various parts of their bodies. But how about preventing hair from growing in the first place? Well, a newly approved product may do just that. And if your patients ask about it, don't bother directing them to one of the over-the-counter aisles--tell them they need a prescription.
The first Rx product of its kind, Vaniqa (eflornithine HCl) cream 13.9% was recently approved for reduction of unwanted facial growth in women. Marketed by Bristol-Myers Squibb and Gillette Co., the drug is actually an antineoplastic and antiprotozoal compound that's already approved in oral form for African sleeping sickness. Eflornithine has also been under investigation for various other conditions, including Pneumocystis carinii pneumonia, malignancies, and psoriasis.
The agent's unique new indication appears to have originated from observations made during oral use of the drug. Studies in the literature have reported inhibition of an enzyme known as ornithine decarboxylase (ODC) in human skin following oral dosing of eflornithine. This ODC enzyme is believed to be necessary for synthetic functions and cell division. Thus, inhibiting ODC would affect the rate of hair growth.
After evaluating a topical form of eflornithine, researchers found that the preparation did indeed retard the rate of hair growth. During clinical trials, eflornithine cream was shown to be effective in slowing growth of facial hair in 60% of women. "The product does take up to two months to work, and, along with using it, women should continue to use their current method of hair removal," noted investigator Marty E. Sawaya, M.D., Ph.D., dermatologist and adjunct professor, department of biochemistry and molecular biology, University of Miami.
According to product labeling, Vaniqa will "improve the condition and the patient's appearance," but she will "likely" need to continue with her previous methods of hair removal indefinitely. The product should certainly not be mistaken for a permanent cure for unwanted hair, since studies indicate hair growth tends to approach pretreatment levels once patients stop using it.
Most commonly reported side effects were minor skin irritations such as temporary redness, hair bumps, stinging, burning, tingling, acne, or rash. Other adverse effects, which occurred in less than 1% of patients, included bleeding skin, cheilitis, contact dermatitis, swelling of lips, herpes simplex, and rosacea. In one open-labeled study, some patients showed an increase in their transaminases.
The reasons behind the product's prescription status appear to be centered around the need for physician assessment of certain patients. "In most cases, unwanted facial hair is caused by hereditary factors. A small number of cases, however, are caused by medical conditions such as androgen excess disorder or polycystic ovarian syndrome. The involvement of a physician is important to determine whether or not an underlying medical condition is the cause of the unwanted facial hair," Sawaya said.
Not surprisingly, dermatologists are predicting that this latest lifestyle drug will be desired not only by hirsute women with excessive facial hair but also by many others who are looking for an easy alternative for controlling hair growth on other parts of their body, such as their legs, underarms, and elsewhere.
RELATED ARTICLE: TIPS TO REMEMBER
Vaniqa
* Vaniqa should be used twice daily, at least eight hours apart.
* Tell patients to apply a thin layer of Vaniqa to affected areas of the face and adjacent involved areas under the chin and rub it in thoroughly. Cosmetics and sunscreens can be applied over treated areas after the cream has dried. Patients should be advised not to wash treated areas for at least four hours.
* Advise patients to continue using hair-removal techniques as needed, in conjunction with Vaniqa. The product should be applied at least five minutes after hair removal.
* Explain to patients that improvement in the condition occurs gradually with Vaniqa. It may be seen as early as after four to eight weeks of treatment, or it may take longer.
* If patients develop skin irritation or intolerance, direct them to temporarily reduce the frequency of application. If the problem persists, patients should discontinue the product.
* Vaniqa has been designated a pregnancy category C drug because of observed deleterious fetal effects in animal studies. Female patients of childbearing age should be warned accordingly.