An antiretroviral drug used to block the transmission of HIV from mother to child could soon be banned by South Africa's Medicines Control Council (MCC) on grounds of safety.
The HIV/AIDS drug nevirapine received approval for local use when activists won a court order forcing the government to provide it to HIV-positive mothers last year.
However, despite a recent thumbs-up by the World Health Organisation (WHO), the MCC could deregister the drug after rejecting results of a key Ugandan study on nevirapine's efficacy.
MCC director, Precious Matsoso, said the 1999 study had numerous flaws and registration would be revoked unless the German manufacturer, Boehringer-Ingelheim, provided additional safety and effectiveness data within 90 days.
"We have to be cautious," Matsoso told Reuters. "If information is available that meets rigorous scientific standards, we will look at it."
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