LAKE PHARMACEUTICAL's YEAST-GARD INGREDIENTS LACK DATA

LAKE PHARMACEUTICAL's YEAST-GARD INGREDIENTS LACK DATA supporting efficacy of the product for the treatment of vaginal yeast infections, FDA asserts in a May 13 warning letter to the firm. The agency pointed out that Lake's Yeast-Gard Medicated Cream and Yeast-Gard Medicated Disposable Douche Premix with Octoxynol-9 are "labeled to contain as active ingredients benzocaine, resorcinol and octoxynol-9." FDA added that it is "not aware of any adequate and well-controlled studies published in the literature that indicate that products containing any of these ingredients are safe and effective for the treatment of vaginal yeast infections." FDA pointed out that the products approved via Rx-to-OTC switch for the treatment of vaginal yeast infections "contain either clotrimazole or micronazole nitrate, and are the subject of adequate and well-controlled studies showing that they are safe and effective for their intended use." The Yeast-Gard Products were brought to FDA's attention through an October 1992 agency inspection of Lake Pharmaceutical's Wheeling, Ill. facility. The agency maintained that product labeling incorrectly implies that Yeast-Gard is effective in treating vaginal yeast infections. For example, promotional fliers for the Yeast-Gard cream attest that it is "gynecologically tested for immediate relief from external vaginal itching and burning." The fliers for the product also declare that it provides "a protective layer of cream over the irritated tissues in order to reduce the chance of further irritation while simultaneously promoting prompt and natural healing." Labeling for the Yeast-Gard douche product claims that it "removes vaginal discharge and relieves minor itching and burning" and that the "active ingredient, octoxynol-9, acts as a mucolytic agent with mild detergent action." FDA also charged that "the term Yeast-Gard" indicates "that these products are intended for the treatment/cure of vaginal yeast infections." It "continues to be our position," the agency said, "that vaginal yeast infections cannot be self-diagnosed" and that vaginal yeast infection treatments on the market should be used "only for recurrent vaginal yeast infections by the laity once their physician has made the initial diagnosis." FDA also cited Lake for making references in product packaging to the "Women's Health Institute." FDA asserted that all references to the Women's Health Institute "imply that the 'institute' has given an independent endorsement to the Yeast-Gard products," adding that the "Women's Health Institute is not an institute, is not independent and is merely a corporate entity of Lake Pharmaceutical." FDA further told the firm that labeling for the douche item, which states that "aloe vera provides naturally soothing relief," implies that "aloe vera is an active ingredient" when it is not. In a June 3 response to FDA, Lake Pharmaceutical contested the charges made in the FDA warning letter, and maintained that the Yeast-Gard products are effective for their indicated uses. A Beaverton, Ore.-based herbal products firm, Bezwecken, also received an FDA warning letter citing products whose labeling implies that they treat vaginal yeast infections. FDA noted in the May 24 letter that labeling for Bezwecken's Yeastat Naturopathic Vaginal Suppositories calls the product "safe and effective for treating candidiasis and chronic mycotic vulvovaginitis" and asserts that it is "effective in treating 98% of the patients who had previously failed to respond to the most common conventional antifungal prescription drugs." FDA charged that "the term Yeastat in the product name and labeling indicates that the product is intended for the treatment of vaginal yeast infections" and, as in the letter to Lake Pharmaceutical, noted that only two ingredients (clotrimazole and miconazole nitrate) are approved for the treatment of vaginal yeast infections. Each Yeastat suppository contains boric acid 600 mg, berberis concentrate 50 mg, calendula 50 mg and hydrastis root 100 mg. Bezwecken told FDA in a June 8 letter that it will change the name of the product to Y-stat boric acid capsules and remove all claims about the treatment of yeast infections. The agency also cited concern with claims made in the labeling of four other herbal products manufactured by Bezwecken: Progonol Moisture Treatment Creme; OstaDerm 1-1-8 Moisture Treatment Creme; OstaB3; and Progon B. Labeling for Progonol, which the firm claimed alleviates premenstrual symptoms, stated that it is "rich in plant extracts and nutrients with TransBase for optimum transdermal nutritional supplementation." Progonol labeling also claimed that the product contains 3.5% progesterone, but "laboratory analysis reveals that this product contains only 2.05% progesterone, that is, 58.6% of the declared amount," FDA pointed out. OstaDerm, which was promoted for the relief of conditions associated with menopause, is represented to contain "tri- estrogens (1-1-8)," but laboratory tests show that it "does not contain the three natural estrogenic substances that would be anticipated from your product literature, that is estradiol, estrone and estriol," FDA told the firm. Progonol and OstaDerm also use a "novel transdermal drug delivery system to convey the active ingredients through the skin" that is not approved by FDA. OstaB3 and Progon B also were promoted for treatment of menopause symptoms. In its June 8 letter to the agency, Bezwecken promised FDA that it would remove all claims from its products and market them only through a catalogue distributed to "naturopathic" doctors and acupuncturists. The firm also said it has destroyed product literature promoting the products as alleviating any health-related conditions and has removed the word "transdermal" from labeling. The company, which used to be called Bezwecken Transdermals, eliminated "Transdermals" from its name to avoid any implication that it markets transdermal drugs.