South Africa: MCC back pedals on nevirapine for mums to be

South Africa’s Medicines Control Council (MCC) has issued a statement stressing that the use of nevirapine for the prevention of mother to child transmission is not `banned` in South Africa, following the publication of full results from the controversial HIVNET 012 study last Friday.

In July the MCC warned nevirapine’s manufacturer, Boehringer-Ingelheim, that the drug’s approval for prevention of mother to child transmission would be rescinded in South Africa unless the company came up with additonal data to support a license for this use within 90 days.

The MCC was concerned that standards of data collection in the HIVNET 012 study were lax, and that important safety information might be missing.

However, South African researchers protested that additional information was available, and called on the MCC to rethink its decision. The MCC has now revealed that it is discussing the data with researchers, and has also extended the period allowed to Boehringer-Ingelheim to present further information.

In its statement, the MCC stressed the importance of preventing mother to child transmission of HIV, and urged healthcare professionals `to use available interventions to improve the survival and health status of both mother and child.`

Long-term evidence for effectiveness of nevirapine in reducing mother-to-child HIV-1 transmission - news story, September 12 2003

Nevirapine conflict eased - no South African ban, PMTCT programmes will continue - news story, August 7 2003

South African doctors condemn nevirapine decision - news story August 9, 2003

South African drug agency questions use of nevirapine for mums to be - news story August 1 2003