A pregnant woman in Indonesia with symptoms of avian influenza agreed to
receive Tamiflu (oseltamivir). The medicine, recommended by the World
Health Organization (WHO) to treat the lethal virus, may be a risk to her
unborn fetus, a doctor said. The 35 year old woman, 2 months pregnant,
began a course of Roche Holding AG's antiviral to treat an infection
possibly caused by the H5N1 avian influenza [virus], said Luhur Soeroso, a
doctor at the Adam Malik Hospital in Medan on Sumatra island.

Clinicians have had little experience treating H5N1 in pregnant women, and
if the woman has the disease, her case may provide needed information.
There is no adequate data on the use of Tamiflu in pregnant women,
according to WHO. Animal studies don't indicate direct or indirect harmful
effects on pregnancy or fetal development, the health agency said in March
[2006]. "Our priority is to save her life," Soeroso said. The woman is
aware of the unknown risks [to] her fetus caused by oseltamivir and by the
antibiotics she is also taking, he said.

H5N1 avian influenza virus is known to have infected 241 people in 10
countries during the past 3 years, killing 141 of them. WHO recommends that
in patients with confirmed or strongly suspected H5N1 infection, doctors
should give oseltamivir as soon as possible. The recommendation applies to
adults, including pregnant women and children, the health agency said in
guidelines for the medical treatment of H5N1 cases, released in May [2006].
There has been "no evidence of a significant risk of fetal abnormalities"
caused by Tamiflu treatment during pregnancy, based on clinical trials and
post-marketing surveillance, said Alexander Klauser, a spokesman for Roche
in Basel, Switzerland. "The majority of women who have taken Tamiflu during
pregnancy have given birth to a healthy baby," Klauser said in an email on
Friday [25 Aug 2006]. "However, given that there are no well-controlled
studies in pregnant women, Tamiflu should not be used during pregnancy
unless the potential benefit to the mother justifies the potential risk to
the fetus."

In the face of a deadly disease such as H5N1, the "risk of oseltamivir in
pregnancy would become insignificant," said K Y Yuen, head of the
Microbiology Department at the University of Hong Kong.