OTC Antifungal Drug Misuse Associated With Patient-Diagnosed Vulvovaginal Candidiasis

Abstract & Commentary

Synopsis: Slightly more than one half of women who purchased antifungal vaginal medications in this survey had demonstrable vulvovaginal candidiasis.

Source: Ferris D, et al. Obstet Gynecol. 2002;99: 419-425.

Ferris and associates attempted to estimate the proportion of women who purchased antifungal over-the-counter (OTC) medications who actually had the disease. They also examined whether a previous history of candidiasis or reading the OTC package label improved a woman’s diagnostic accuracy.

Ferris et al collected cases from 5 urban areas. Women were required to be 18 years of age or older, were in the process of purchasing an antifungal medication, and presented for examination prior to using the purchased material. The women were recruited by pharmacists and other employees of pharmacy and grocery stores in the study cities. Despite having a metropolitan female population of several million, only 104 women were initially enrolled in the study during the 4-month study window. Of these, 9 were excluded.

All of the women who agreed to participate in the study were examined within 24 hours of their product purchase. All women had microscopic evaluation of their vaginal secretions. Multiple cultures were obtained, as well as a Gram stain of the vaginal secretion. Cultures for chlamydia and gonorrhea were performed.

Only one third of the women had vulvovaginal candidiasis alone, but a total of 53.5% had candidiasis with or without bacterial vaginosis or trichomonas. Overall, only 13 of the 95 women were found to be completely normal. (Of interest, Ferris et al do not comment on their interpretation of the reason these women were having symptoms.)

Based on these results, Ferris et al conclude that nearly half the women in their sample were wasting their personal health care dollars by purchasing OTC antifungal agents. They also suggest the primary beneficiaries of the OTC availability of these medications are the pharmaceutical companies. However, they do suggest that because nearly one half of the women did have a yeast infection and would presumably have been cured of that condition with the OTC medication without a physician examination, the overall health care industry expense might be less than when these medications were only available by prescription.

Comment by Kenneth L. Noller, MD

This article represents another in an ever-lengthening series that has shown that many women who purchase OTC antifungal medications for the treatment of yeast vulvovaginitis do not, in fact, have that disease. I really don’t think that fact should surprise anyone, as even clinicians have been known to misdiagnose a vulvovaginal candidiasis with some frequency.

The interesting part of this article was Ferris et al’s examination of the usefulness of the "restrictions" the FDA placed on the use of these medications. These were that the medications should only be used in women who had previously had a clinician-confirmed case of candidiavaginitis, and that they have read the product package. Ferris et al found that women who actually had vulvovaginitis were no more or less likely to have fit these 2 restrictions than women who did not have the disease. Clearly the FDA has not provided useful guidance in this case.

While Ferris et al largely avoided it, I am somewhat tired of having clinicians whine about the fact that these drugs are available OTC since some women who take them do not actually have yeast vulvovaginitis. Virtually all OTC medications are used inaccurately on some occasions. For example, I have no doubt that some individuals who purchase aspirin because they have a headache actually have a brain tumor for which the aspirin will not provide relief. Does that mean aspirin should be taken off the market?

My only concern with these OTC antifungal agents is that some women use them repeatedly because they are not "cured." I have frequently seen women in the office that have vulvar injuries due to repeated use. I would truly like to see the FDA require that each of these packages state, in bold-face type, that they should not be reused if symptoms do not disappear or recur within a short period of time.

Dr. Noller is Professor and Chairman, Department of OB/GYN, Tufts University School of Medicine, Boston, Massachusetts.