Controlling Yeast Infections : Diagnosis

by Food and Drug Administration (FDA)

(Page 2 of 3)

Diagnosing vaginal yeast infections can be tricky, especially at first. Several other disorders, including inflammation of the cervix or sexually transmitted diseases such as trichomoniasis (a parasitic infection) or herpes, can have similar symptoms.

According to Mead, clinical diagnosis of yeast infections starts with a slide of vaginal secretions examined under the microscope. "Those slides [can be] very specific. If you see the yeast organisms, you can assume that's the diagnosis."

(Slides are actually examined for a particular stage of the fungus form called mycelia. While yeast is a commonly present form of fungus, mycelia is the variation of the fungus type that can grow out of control and cause infection problems.)

It's possible to have a yeast infection that doesn't show up in the limited examination of a single slide smear. Mead says that if a woman has a negative slide smear, but still has significant symptoms, her physician is likely to order a culture.

For example, there is one variety of candida — Candida glabrata — that causes symptoms but does not characteristically show up under the microscope. For that, a culture may be necessary. "A culture is more sensitive," says Mead. "It should pick up virtually anything."

While studies have shown that women are able to correctly identify recurring vaginal yeast infections most of the time, there is still some concern about misdiagnosing and mistreating other problems that may mimic symptoms. Through package and product labeling of products sold without prescription, FDA and pharmaceutical companies are working to make sure that women with an infection that differs even slightly from the symptoms of a previous yeast infection return to their doctors.

OTC Availability — With Warnings

Until 1990, drugs to treat vaginal yeast infections were available only by prescription. In December 1990, after receiving the advice of a number of experts, FDA gave Schering-Plough HealthCare the go-ahead to market and sell over-the-counter its antifungal medication Gyne-Lotrimin, a brand name for clotrimazole. It has been joined by several other products that are either clotrimazole or another antifungal, miconazole nitrate. (The first miconazole nitrate drug to be allowed to be sold OTC for vaginal yeast infections was Advanced Care Products' Monistat 7.)

Both clotrimazole and miconazole nitrate are from the same anti-fungal drug family and work very similarly by breaking down the cell wall of the yeast organism, causing it to dissolve completely.

The products are supplied in one of two ways: as vaginal inserts or suppositories or as a cream with a special applicator. Both formulations are for use at bedtime every night for seven nights.

While most women note improvement within just a few days, it's important to finish the seven-day treatment to make sure all of the troublemaking fungus has been disabled. Women who don't see rapid improvement of their symptoms are likely to have a problem other than a vaginal yeast infection.

"The benefit [of OTC sale of these products] is that they are readily available for women to purchase without having to go to a physician," says Joseph Winfield, M.D., a medical officer in FDA's anti-infective drugs division. Ready availability of OTC treatments means that women no longer have to suffer while waiting for an appointment, or rearrange work and family life to find time to go to the doctor's office for a recurrent infection.

"Vaginal candidiasis is a rather common occurrence," says Winfield. "It doesn't present any life-threatening condition to the individual [with an infection] and it's okay to treat over the counter — but only for women [who] have had an infection diagnosed by a physician previously. As those same symptoms recur, they should be able to treat themselves."

In October 1992, FDA required additions to printed information accompanying OTC products for vaginal yeast infections. One significant addition to the patient package insert was a notice that recurrent vaginal yeast infections, especially those that do not clear up easily with proper treatment, may also be the result of serious medical conditions, including HIV infection. The labeling also says: If you experience vaginal yeast infections frequently (they recur within a two-month period) or if you have vaginal yeast infections that do not clear up easily with proper treatment, you should see your doctor promptly to determine the cause and to receive proper medical care.

"While it is true that women who are HIV-infected are much more likely to have chronic vaginal yeast infections," says Mead, "most women with recurrent vaginal yeast infections aren't HIV-positive [HIV-infected]."

In addition to the HIV notice, the following warnings also appear on information accompanying the products:

• Do not use if you have abdominal pain, fever, or foul-smelling vaginal discharge. You may have a condition that is more serious than a yeast infection. Contact your doctor immediately.
• Do not use if this is your first experience with vaginal itch and discomfort. See your doctor.
• If there is no improvement within three days, you may have a condition other than a yeast infection. Stop using this product and see your doctor.
• If symptoms recur within a two-month period, contact your doctor.
• Do not use during pregnancy except under the advice and supervision of a doctor.
• This medication is for vaginal yeast infections only. It is not for use in the mouth or the eyes. If accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
• Keep this and all other drugs out of the reach of children. This product is not to be used in children less than 12 years of age.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.