Pregnant bird flu patient may add to information on Tamiflu

The 35-year-old woman, two months pregnant, began a course of Roche Holding AG’s antiviral to treat an infection possibly caused by the H5N1 avian influenza strain, 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, known scientifically as oseltamivir, in pregnant women, according to the WHO. Animal studies don’t indicate direct or indirect harmful effects on pregnancy or fetal development, the health agency said in March.

“Our priority is to save her life,” Soeroso said. The woman is aware of the unknown risks on her fetus caused by oseltamivir and by the antibiotics she is also taking, he said.

The virus, which threatens to mutate and spark a global outbreak, is known to have infected 241 people in 10 countries during the past three years, killing 141 of them.

The 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.

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 e-mail Friday. “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.

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