U.S. ISSUES WARNING ON USE OF
Reuters 4 Jan. '01
Atlanta -- Health-care workers who take nevirapine after possible
occupational exposure to the AIDS virus risk potentially life-threatening
side effects from the anti-AIDS drug, federal health officials said on
The Centers for Disease Control and Prevention (CDC) said it found 22
reported cases of serious side effects among people who took the drug
fearing exposure to HIV, the virus that causes AIDS, because of a
needlestick or similar injury.
Dr. Elise Beltrami of the CDC's National Center for HIV, STD and TB
Prevention said the side effects have included liver toxicity and severe
skin reactions. In one case, a 43-year-old health-care worker needed a
liver transplant after suffering liver failure.
Nevirapine, sold under the name Viramune, is approved for use as an
antiviral drug for people with HIV infection. It is also used to prevent
transmission of HIV from a pregnant woman to her child.
However, the CDC said that because most occupational exposures to HIV do
not result in transmission of the virus, the risk of side effects from
nevirapine should be balanced against the risk of HIV transmission.
"In this setting, the risk of HIV transmission is very low and, in most
cases, the risk of taking nevirapine would outweigh the risk of using it
for possible prevention of HIV,'' Beltrami said.
The drug's manufacturer, Boehringer Ingelheim/Roxane Laboratories, Inc.,
notified health professionals in November that it was strengthening product
package warnings because of continued reports of "severe, life-threatening
and in some cases, fatal hepatotoxicity.''
Beltrami said the adverse reactions reported among health- care workers
"do not, in any way, apply to the use of nevirapine in other settings.''
"Nevirapine has been shown to be safe as a single-dose treatment for
prevention of perinataltransmission of HIV,'' Beltrami said.
"It also should not affect the use of nevirapine for HIV-infected
individuals where nevirapine can be used in combination with other
anti-retroviral agents with appropriate monitoring,'' she said.