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DHHS Perinatal Panel Notice on Nelfinavir FDA-Pfizer Letter – September 11, 2007
DHHS Perinatal Panel Notice on Nelfinavir FDA-Pfizer
September 11, 2007
The DHHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal
Transmission wants to bring the following notice from the FDA and letter from Pfizer to your
attention regarding use of Viracept (nelfinavir mesylate) in pregnant HIV-infected women. Due
to potential concerns related to the presence of ethyl methane sulfonate in Viracept (nelfinavir)
(see below), it is recommended that:
1. When considering the risk/benefits for use of Viracept (nelfinavir), the needs of the
individual patient must always be considered.
2. Pregnant women who need to begin antiretroviral therapy or prophylaxis should not be
offered regimens containing Viracept (nelfinavir) until further notice, but rather begin an
alternative antiretroviral regimen.
2. Pregnant women who are currently receiving Viracept (nelfinavir) should be switched to
an alternative antiretroviral regimen.
3. For pregnant women with no alternative treatment options, the risk-benefit ratio remains
favorable for the continued use of Viracept (nelfinavir) in these women. In such women,
the critical importance of maintaining maternal health status and preventing mother to
child transmission outweighs the potential risks.
4. Alternative antiretroviral drugs for regimens are listed in Table 3 of the
Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women
for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the
United States. The other recommended protease inhibitor for use in pregnant women is
Lopinavir/ritonavir (Kaletra). Recommended alternative protease inhibitors include
indinavir (boosted with ritonavir) or saquinavir (boosted with ritonavir).
The Antiretroviral Pregnancy Registry monitors the rate of birth defects in infants born to
pregnant women receiving antir