Published 20 August 2008, doi:10.1136/bmj.a1385
Cite this as: BMJ 2008;337:a1385

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South Africa withdraws TB drugs because of quality concerns

¹ Johannesburg

The first 150 words of the full text of this article appear below.

South African health authorities have withdrawn two generic drugs widely used in the country to treat tuberculosis, amid concerns about their quality.

When the health minister, Manto Tshabalala-Msimang, announced the withdrawal earlier this month she said that her department had received information suggesting that the ingredients in the two combination drugs, called Antib-4 and Ebsar, "were not at the level stated in the label after storage."

Antib-4 combines pyrazinamide, ethambutol, isoniazid, and rifampicin. Ebsar is a combination of isoniazid and rifampicin.

Both drugs are manufactured in India by Rusan Pharma and imported into South Africa, where they are registered to another company, MDI.

The health minister said that a laboratory accredited by the World Health Organization had found that at least two of the four ingredients in Antib-4 and both ingredients in the other drug were below the required level.

Further tests are being undertaken before the Medicines Control Council . . . [Full text of this article]

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