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DHHS Pediatric Panel Notice on Nelfinavir FDA-Pfizer Letter – September 11, 2007
DHHS Pediatric Panel Notice on Nelfinavir FDA-Pfizer
September 11, 2007
The DHHS Panel on Pediatric Antiretroviral Therapy and Management Guidelines wants to
bring the following notice from the FDA and letter from Pfizer to your attention regarding use of
Viracept (nelfinavir mesylate) in HIV-infected children. Due to potential concerns related to the
presence of ethyl methanesulfonate 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. For pediatric patients who are currently receiving Viracept (nelfinavir)-containing
regimens and are stable, the risk-benefit ratio remains favorable for the continued use of
Viracept (nelfinavir). In such children, the critical importance of maintaining the child’s
health status outweighs the potential risks.
3. Pediatric patients who need to begin antiretroviral therapy should not be offered
regimens containing Viracept (nelfinavir) until further notice, but rather begin an
alternative antiretroviral regimen.
4. For children just starting therapy, alternative protease inhibitor antiretroviral drugs
for regimens are listed in Table 7 of the Guidelines for the Use of Antiretroviral Agents in
Pediatric HIV Infection. The recommended protease inhibitor for initial therapy in
children is lopinavir/ritonavir (Kaletra).
Viracept (nelfinavir mesylate) is a protease inhibitor antiretroviral medicine used in combination
with other anti-HIV medications to treat infection with HIV. It is approved for use in adults and
in children older than 2 years of age who are infected with human immunodeficiency virus
(HIV-1), the virus that causes acquired immune deficiency syndrome (AIDS).
Earlier this summer, Viracept was recalled from the European market due to high levels of a