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FDA Public Health Advisory for Nevirapine (Viramune)

January 19, 2005

The Food and Drug Administration (FDA) is issuing a public health advisory to inform health care providers and patients about recent safety-related changes to the nevirapine (Viramune) label (package insert) and about appropriate use of HIV triple combination therapy containing nevirapine, which is one treatment option in the United States and which is increasingly being used globally. The nevirapine label has been revised several times over the last two years to include more information on liver toxicity associated with long-term nevirapine use. The Indications and Usage section of the Viramune label now recommends against starting nevirapine treatment in women with CD4+ cell counts greater than 250 cells/mm3 unless benefits clearly outweigh risks. This recommendation is based on a higher observed risk of serious liver toxicity in patients with higher CD4 cell counts prior to initiation of therapy. In addition, the revised label now includes a Medication Guide to inform patients about risks associated with nevirapine when used for the treatment of HIV.

Both clinically symptomatic and asymptomatic liver toxicity are observed with long-term use of nevirapine in combination with other HIV drugs. Asymptomatic liver toxicity is defined as increases in liver enzymes without any associated clinical signs or symptoms and is similar to that seen with other antiretroviral drugs. Symptomatic liver toxicity is more common with nevirapine compared to other antiretroviral drugs. Important information regarding symptomatic nevirapine liver toxicity is summarized below:

In spite of the potential for serious and life-threatening liver toxicity and skin rashes with nevirapine, there are multiple reasons why nevirapine remains an important part of an HIV treatment regimen for many HIV-infected individuals world-wide. These reasons include:

In conclusion, the seriousness of the underlying disease must be considered as part of the risk benefit analysis when treating HIV-infected patients. HIV infection will progress to AIDS and death if untreated. Treatment with combination antiretroviral drugs, including nevirapine, can slow clinical progression and may delay the development of AIDS or death for years. Health care providers should weigh the benefits and risks associated with nevirapine use before prescribing nevirapine for the treatment of their HIV-infected patients.

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