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No evidence that contaminated nelfinavir led to increased risk of birth abnormalities or cancer
Michael Carter, 2016-10-10 06:40:00
infants potentially exposed in utero
to doses of the HIV protease inhibitor nelfinavir (Viracept) contaminated with the toxic
compound ethyl methyl sulfone (EMS) did not have an increased risk of birth
abnormalities, nor is there any increased risk of cancer, according to French
research published in the online edition of AIDS.
“These data are
generally reassuring about the health of children exposed in utero to the EMS contamination,” write the authors.
May 2007 and July 2008, batches of nelfinavir were contaminated with EMS, a
powerful toxin associated with birth abnormalities and an increased risk of
cancer. The contamination resulted in the recall of all batches of the drug
and ultimately in the manufacturer, Roche, ceasing production of nelfinavir.
analysis of contaminated batches showed that the potential exposure was
substantially below levels capable of damaging health. A study of cancer
incidence among exposed patients had reassuring findings, showing that the risk
of malignancies was no higher than that observed in people taking
non-contaminated nelfinavir or other protease inhibitors.
At the time of the
recall, nelfinavir was no longer a first-line antiretroviral. However, because
of its good safety profile, the drug was a preferred option for the treatment
of pregnant women with HIV and the prevention of vertical (mother-to-child)
transmission of HIV.
were concerned that although the levels of EMS contamination may have been
non-toxic for children and adults, they may nevertheless have been
toxic for embryos and foetuses, especially given that EMS is known to pose a
risk of birth abnormalities.
Perinatal Cohort routinely gathers data on birth defects and cancer incidence
among HIV-exposed infants and therefore provided investigators with a large
dataset to determine whether in utero
exposure to EMS-contaminated nelfinavir had adverse effects.
first examined data on birth abnormalities, comparing rates among newborns
exposed to nelfinavir during and outside the contamination periods. There was
no difference between the two periods, regardless of trimester of exposure to
investigators compared cancer incidence among infants and children exposed to
nelfinavir in utero outside and
during the EMS contamination periods. Incidence was 8.5 per 100,000
person-years of follow-up for infants and children exposed to the drug outside
the contamination period, and 0 per 100,000 person-years for those exposed during the
“The incidence of
malformation was similar to that of the cohort as a whole with different drug
exposure,” conclude the authors. “No children developed cancer after 9 years of