Labeling
Updates to Genital Herpes Drug - Valtrex
The FDA
has revised the labeling for the drug Valtrex (valacyclovir
hydrochloride) to include using it to reduce the risk of transmitting
genital herpes to heterosexual partners with healthy immune
systems.
Genital
herpes is a common sexually transmitted infection caused by
herpes simplex viruses (HSV). Many individuals have no or
minimal symptoms from genital HSV infection and may transmit
the virus during sexual contact when they show no signs of
genital lesions.
The FDA
based its decision to allow this additional use for Valtrex
on the results of a placebo-controlled study conducted by
the manufacturer, GlaxoSmithKline of Research Triangle Park,
N.C. Researchers found that the risk of transmission is reduced
when Valtrex is taken daily to suppress outbreaks and when
safe sex practices are followed.
At the
beginning of the study of 1,500 heterosexual couples, only
one member of each couple had evidence of genital herpes.
Study results showed a 48 percent reduction in the transmission
of genital herpes from the infected partner to the uninfected
partner among those taking Valtrex.
The following
safe sex practices lower the chances of passing genital herpes
to a partner:
- Use
a condom made of latex or polyurethane when you have sexual
contact.
- Do
not have sexual contact with your partner when you have
any symptom or outbreak of genital herpes.
The FDA
had previously approved Valtrex to be taken episodically--when
a person has a genital herpes outbreak or feels one coming
on, or suppressively--daily to help suppress the recurrence
of outbreaks. Valtrex is also approved to help heal the lesions
and to lessen the pain of an initial episode of genital herpes.
Valtrex
may cause kidney and nervous system problems in individuals
who already have kidney disease and in older people who have
age-related kidney problems. People with kidney problems or
other medical conditions should consult their health care
providers before taking Valtrex.
source: FDA
Consumer magazine
Nov. - Dec. 2003
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