Women and AIDS : Drug Labels, Treatment

by Food and Drug Administration (FDA)

(Page 2 of 4)

Drug Labels Provide Warning

To help increase awareness about the most common early indicator of HIV infection in women — recurrent vaginal candidiasis (yeast infections) — FDA in October 1992 required manufacturers of over-the-counter drugs for these infections to include a new label warning on their products.

The warning states that frequent vaginal yeast infections (recurring within a two-month period) — especially those that don't clear up easily with proper treatment — may be the result of serious medical conditions, including HIV infection, and advises women with these symptoms to see their doctors. (Recurrent yeast infections also may result from hormonal changes or use of oral contraceptives or antibiotics, as the label already noted.) Examples of over-the-counter preparations that must carry these warnings are Monistat-7 (miconazole nitrate); Gyne-Lotrimin, Mycelex-7, and FemCare (clotrimazole); Femstat 3 (butoconazole nitrate); and generic versions of these products. Manufacturers of oil-containing or oil-based vaginal creams for treating yeast infections and other vaginal infections must also warn patients not to rely on latex barrier contraceptives, such as latex condoms or diaphragms, when using their products. The cream may cause the latex to weaken or break.

Other illnesses and infections in women that should prompt concern about possible HIV infection include pelvic inflammatory disease (PID), cervical dysplasia (precancerous changes in the cervix), yeast infections of the mouth and throat, and any sexually transmitted disease, such as genital ulcers and warts and herpes infection.

In February 1995, FDA published a proposed rule in the Federal Register to require manufacturers of over-the-counter spermicides to submit data showing their products are effective as contraceptives. The agency also strongly encouraged manufacturers to evaluate these products for prevention of sexually transmitted diseases, including HIV. Though the administrative record for this rule originally closed on April 3, 1996, after discussions with industry, FDA reopened the record, with the comment period ending March 3, 1997.

AIDS Definition Revised

A doctor diagnoses AIDS when an HIV-infected person develops one of several infections or diseases specified by CDC in its "AIDS surveillance case definition." These illnesses include PCP (Pneumocystis carinii pneumonia), Kaposi's sarcoma (a type of cancer), toxoplasmosis, and others. As knowledge about HIV and AIDS has grown over the years, CDC has expanded its definition to include additional AIDS-defining illnesses. In January 1993, CDC added cervical cancer, along with pulmonary tuberculosis and recurrent pneumonia, to the list of AIDS-indicator illnesses in HIV-infected people.

The revised AIDS definition also includes all HIV-infected people with severe CD4 cell depletion (less than 200 CD4 cells per cubic millimeter). CD4 cells are critical immune system cells that number from about 800 to 1,000 in a healthy person.

According to the earlier definition, a person with a very low CD4 count but no AIDS-defining illness was not included in the case definition of AIDS.

Treatment

Available data suggest that drugs used to treat HIV work similarly in men and women. These drugs are usually grouped by the way they fight the virus. When this special issue went to press, approved agents included:

Reverse Transcriptase Inhibitors:

Non-nucleosides: Viramune (nevirapine)

Nucleosides:

• Retrovir (zidovudine, also known as AZT)
• Videx (didanosine, also known as DDI)
• Hivid (zalcitibine, also known as DDC)
• Zerit (stavudine, also known as d4t)
• Epivir (lamivudine, also known as 3TC)

Protease Inhibitors:

• Invirase (saquinavir))
• Norvir (ritonavir))
• Crixivan (indinavir) )

Data that became available in 1996 has given new hope to people with HIV infection. For the first time, combinations of new and older agents and the availability of the newer monitoring techniques have demonstrated that therapies can dramatically reduce the amount of virus measurable in the blood. This is often associated with improved health.

The AIDS Clinical Trials Information Service (ACTIS) can provide current information on federally and privately sponsored HIV and AIDS drug and vaccine clinical trials, free customized searches of national clinical trials and drug databases, and confidential, personalized assistance from English- and Spanish-speaking health specialists. (See "Information Sources.")

Certain infections may be more severe or prolonged or occur more frequently in people with HIV infection, and so may require different forms of therapy. For example, some doctors may prescribe oral antifungals for vaginal yeast infections in HIV-infected women instead of the commonly used vaginal products.

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.