1.4 Impurity how damage the DNA this HIV Drug
Viracept (DNA damage)
11 Sep 2007 Drug Company Pfizer Inc together with the US
Food and Drug Administration (FDA) warned yesterday,
Monday, that its HIV drug Viracept (nelfinavir mesylate)
may be contaminated with a potential carcinogen and asked
doctors not to start pregnant women or children on the drug.
Children who are already on the drug and are stable may
continue to take Viracept, but pregnant women should be
switched to an alternative antiretroviral said Pfizer and the
FDA. The drug company issued a Dear Healthcare
Professional letter about the presence of an impurity, ethyl
methanesulfonate (EMS), that has entered the Viracept
formula during the manufacturing process. The letter also
gives guidelines on the use of Viracept in pediatric patients
and pregnant women. Although no human studies exist,
EMS is considered a potential human carcinogen: animal
studies indicate it to be teratogenic (causing birth defects),
mutagenic (causing mutation through DNA damage) and
carcinogenic (causing cancer). In the meantime the FDA has
asked Pfizer to limit the amount of EMS in its US
1.4 Impurity how damage the DNA this HIV DrugViracept (DNA damage)11 Sep 2007 Drug Company Pfizer Inc together with the USFood and Drug Administration (FDA) warned yesterday,Monday, that its HIV drug Viracept (nelfinavir mesylate)may be contaminated with a potential carcinogen and askeddoctors not to start pregnant women or children on the drug.Children who are already on the drug and are stable maycontinue to take Viracept, but pregnant women should beswitched to an alternative antiretroviral said Pfizer and theFDA. The drug company issued a Dear HealthcareProfessional letter about the presence of an impurity, ethylmethanesulfonate (EMS), that has entered the Viraceptformula during the manufacturing process. The letter alsogives guidelines on the use of Viracept in pediatric patientsand pregnant women. Although no human studies exist,EMS is considered a potential human carcinogen: animalstudies indicate it to be teratogenic (causing birth defects),mutagenic (causing mutation through DNA damage) andcarcinogenic (causing cancer). In the meantime the FDA hasasked Pfizer to limit the amount of EMS in its US
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