Chris Van Gass
12 August 2008
Cape Town — The health department has withdrawn two tuberculosis (TB) drug products that were more than four months old.
This after information was received from a "whistle-blower" suggesting the ingredients in the drugs were substandard, Health Minister Manto Tshabalala-Msimang said yesterday.
The minister told a media briefing in Parliament an investigation was under way to test the stability of the drugs, used in the treatment of TB and supplied by pharmaceutical firm Pharmascript.
She also said all TB fixed-drug combinations on tender were being tested. The drugs are used in the primary care of TB.
She said a World Health Organisation-accredited laboratory at North West University was testing the products and the results on their stability would be available only in October.
However, as a precautionary step the department had decided to withdraw Antib-4, a four-in-one combination of drugs, and Ebsar, a two-in-one combination of drugs. She said Pharmascript had agreed to provide the replacement stock at the required frequency, pending the investigation.
Pharmascript MD Graham Somerville, said the company was co-operating "fully" with the department and had done so for the past week to get to the cause of the problem.
He said Pharmascript was also conducting its own tests .
Tshabalala-Msimang said results of the analysis on stocks on the shelves for six months indicated the products complied with levels claimed in the label.
Yet results of a three-month accelerated stability test on the same batch indicated that in the four-in-one drug at least two of the four ingredients were below the level claimed.
In the two-in-one drug combination, both ingredients were found to be below the required level.
She said confirmatory tests on the results were being conducted before action could be taken by the Medicine Control Council. She did not want to say what action this would be until the results of the tests were available.
She appealed to all patients in possession of the two suspect batches to consult their health professionals to establish possible side effects.
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In some peoples eyes the department of wealth,when is our administration going to administrate,then we might not have to wait for whistleblowers,we could be very sure of the quality of things.