The pharmaceutical company Boehringer Ingelheim (BI) makes the anti-HIV drug nevirapine (Viramune), which is used as part of combination therapy in the treatment of HIV/AIDS. Nevirapine's side effects include rash, and in rare cases, liver damage. The American office of BI recently issued a letter to heath care professionals in that country drawing their attention to the following:

• Women who have more than 250 CD4+ cells, including pregnant women who use nevirapine, are at greatly increased risk of liver damage. In some cases, the liver damage has been fatal.
• The company adds that the greatest risk of "severe and potentially fatal liver damage" occurs during the first six weeks of nevirapine use and that this liver damage is "often associated with rash." Because the risk of these complications can continue beyond the initial six weeks of use, BI advises that nevirapine users need to be closely monitored for the first 18 weeks of treatment. Close monitoring is essential as in some cases liver injury may grow worse despite stopping treatment.

BI reminds health care professionals that if any sign/symptom of nevirapine-associated liver damage or skin rash should occur, patients should be told to stop taking the drug and seek immediate medical help. In addition to rash, the following may also occur:

• fever
• blisters
• sores/lesions in the mouth
• itching or burning eyes, eyelids
• swelling of the face
• muscle or joint pain
• unexpected tiredness

Although it is uncommon, severe and life-threatening liver damage has occurred in some people taking nevirapine. This is why the company advises that close monitoring by physicians—particularly for the first 18 weeks of nevirapine therapy—is essential. Signs/symptoms of liver damage can include the following:

• loss of appetite
• nausea
• vomiting
• yellowing of the skin (jaundice) and eyes
• abdominal pain

Although the letter highlights the risk faced by women, BI notes that "any patient" who uses nevirapine can experience liver injury and should be carefully monitored by his or her doctor. And, as always, in cases of severe rash or severe liver damage, once a person discontinues nevirapine it should never be restarted.

Reporting side effects

In Canada, both physicians and patients may report side effects to Health Canada's Adverse Drug Reaction Monitoring Program using the following contact information:

• toll-free telephone: 866.234.2345
• toll-free fax: 866.678.6789

In the United States, the Food and Drug Administration's MEDWatch program may be contacted at:

• telephone: 800.332.1088
• fax: 800.332.0178

REFERENCE

Shepard KV. Re: clarification of risk factors for severe, life-threatening and fatal hepatotoxicity with Viramune (nevirapine). Dear health care professional letter February 2004.

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