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'Nevirapine is safe - at least for now'
Di Caelers. Cape Argus, August 16 2002. Reprinted courtesy of Independent Newspapers (Pty) Ltd.
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Nevirapine is safe - at least for now. Medicines Control Council (MCC) registrar Precious Matsoso on Friday made it clear to parliament's health committee that the council had no plans to ban the anti-AIDS drug used to help prevent mother-to-child HIV transmission.
But there was an indication the drug's status may change, depending on future documentation expected to be provided by manufacturer Boehringer-Ingelheim next month.
The health committee asked MCC officials to update them on nevirapine's status after newspaper reports that nevirapine was to be deregistered.
The controversy centres around administrative problems with the Ugandan nevirapine study which emerged when Boehringer-Ingelheim applied for approval for mother-to-child use of the drug in the US from the Food and Drug Administration there.
Last week the company said they stood by the clinical findings of the study and that current reorganisation of the Ugandan data would clear up any question marks.
At Friday morning's meeting, Jonathan Levine, member of the MCC's clinical trials committee, said no major safety concerns had been raised in clinical data from nevirapine studies.
Matsoso told the health committee that in the past two weeks nevirapine's conditional approval in the European Union countries had been lifted and permanent approval granted. But she said it was her council's job to review conditions it had set around the use of nevirapine in SA from time to time, checking compliance and any adverse reactions.
The current review followed Boehringer-Ingelheim raising issues about the data integrity of the Ugandan study (after its withdrawal for approval in the US).
"Our review is as a result of this signal about problems in Uganda with data. We are reviewing it to check whether the integrity of the data was compromised.
"But we are not banning or deregistering nevirapine," Matsoso said.
AIDS activist and Treatment Action Campaign head Zackie Achmat said after the meeting that he would like to see clear communication that nevirapine was a safe and effective treatment.
Earlier this year they won a High Court and Constitutional Court battle to force the government to ensure access to nevirapine to all HIV-positive pregnant women in South Africa. |
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