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Fusion in pregnancy
Nov 29, 2004

Don, can Fusion be safely used in pregnancy? Thank you Attie van Niekerk

Response from Mr. Kurtyka

Attie,

There is a categorical system for use of drugs in pregnancy. The safest drugs are in Category A, followed (in order) by Category B, C, D and X. A good web site for this is www.safefetus.com. Here's their description regarding category B agents:

"Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters)."

All of the currently approved HIV antiretroviral drugs are either Category B or Category C.

According to the Fuzeon product insert, Fuzeon has been used in pregnant rats and rabbits up to 27 times and at doses 3.2 times the adult human dose and there was no harm to the fetus. There have not been adequate and well-controlled studies in humans.

The bottom line is like all other antiviral drugs, there are no great studies that demonstrate safety during pregnancy. However, women who are pregnant routinely take antiretrovirals for their own health and to reduce the likelihood of HIV transmission to the baby. Have a chat with your healthcare provider and learn more about using ARVs during pregnancy. You may want to ask about participating in the Antiviral Pregnancy Registry so that more data can be collected regarding use of these drugs in pregnancy.

--dk

Safe Fetus



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