Side effects

New warning about nevirapine liver toxicities issued by manufacturer

Michael Carter
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Boehringer Ingelheim, the manufacturer of the non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine (Viramune) has issued important new safety information in a letter to doctors in the US about the drug’s potentially fatal liver toxicities.

Safety information contained in packets of the drug will now caution that women with CD4 cell counts above 250 cells/mm3, including pregnant women, who are taking nevirapine for chronic HIV infection, have a twelve-fold greater risk of serious liver side-effects, and that these have sometimes been fatal.

Liver events present the greatest risk of fatality if they occur in the first six weeks of nevirapine treatment, and are often associated with a rash. However, the risk continues after this time and Boehringer Ingelheim is cautioning doctors to closely monitor patients for the first 18 weeks of nevirapine therapy.

Glossary

hepatic

To do with the liver.

rash

A rash is an area of irritated or swollen skin, affecting its colour, appearance, or texture. It may be localised in one part of the body or affect all the skin. Rashes are usually caused by inflammation of the skin, which can have many causes, including an allergic reaction to a medicine.

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). 

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

liver function test (LFT)

A test that measures the blood serum level of any of several enzymes (eg, AST and ALT) produced by the liver. An elevated liver function test result is a sign of possible liver damage.

Even when nevirapine treatment is discontinued, the manufacturer is warning that in some instances hepatic injury has continued to progress.

Boehringer Ingelheim also uses its letter to remind healthcare providers that any patient taking nevirapine can experience hepatic toxicities. Because of this some doctors recommend that nevirapine-treated individuals should be monitored more often than once a month. In particular, it is recommended by some experts that liver function be monitored before nevirapine treatment is started, at the time of nevirapine dose escalation and two weeks later.

It’s also stressed by the drug company that any patient developing a rash on nevirapine treatment should have a liver function test immediately, particularly during the first 18 weeks of therapy with the drug.

In addition, the company is stressing that patients should be provided with information about signs and symptoms of hepatitis, skin reactions to nevirapine and hypersensitivity to the drug. They add that patients experiencing an allergy to nevirapine should “discontinue…treatment and seek medical evaluation immediately” and stress that nevirapine “should not be restarted in these patients.”

This advice has been approved by the US Food and Drug Administration. It is expected that similar advice in Europe will be issued very soon.

Further information on this website

Nevirapine - overview

The liver - factsheet

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