ANTIB-4, a four-in-one combination of the drugs PZA, Ethambutol, Isoniazid and Rifampicin, and EBSAR, a two-in-one combination of Isoniazid and Rifampicin, – both indicated for primary TB – have been withdrawn from circulation if four months or older and replaced with new stock by the provider Pharmascript.
Medicines Control Council registrar Dr Mandisa Hela said yesterday (SUBS: Monday) that is was difficult to know at this stage if any patients had been affected, but that preliminary investigations showed that some provinces were out of stock as there was fast turnover of the drug. This meant that the damage could be limited.
‘This is a precautionary measure we are taking,’ said Hela.
She said the health department initiated the investigation after receiving information from a ‘whistleblower’ that there ‘might be quality problems’.
The drug is used to treat primary TB and is not used at all for the treatment of multi-drug or extensively-drug resistant TB.
Health minister Dr Manto Tshabalala-Msimang said after receiving the information, the health department requested North-West University’s World Health Organisation accredited laboratory to conduct a series of tests on the two drugs.
A three month accelerated stability test was conducted showing that in the four-in-one drug, at least two of the four drugs were found to be below the levels claimed on the label.
On the two drug combination, both ingredients were found to be below the required level. Further tests are being conducted on the stability of these drugs with the final results expected at the end of October.
The minister said all TB fixed-drug combinations on tender were also being investigated and these outcomes would also be released at the end of October.
Tshababalala-Msimang said she expected the pharmaceutical companies to ‘come on board and help us’.
‘It will be a pity if the results show that no matter how much we are trying (to fight TB), we have been giving them (patients) sub-optimal drugs. We can only pray to the Almighty,’ she said.
Tshabalala-Msimang also expressed concern over the reported mix-up in the packaging of the antiretroviral (ARV) batches of AZT and Nevirapine that had been manufactured by Adcock Ingram.
Adcock Ingram announced last week that nearly half a million ARV tablets were being recalled across the country because a drug company factory worker made a packing error a year ago.
Adcock Ingram retrieved nine boxes marked as AZT, but wrongly packed with Nevirapine and is recalling thousands of boxes.
The problem arose when a worker packed Nevirapine into boxes for AZT. The Nevirapine blister packs were correctly labeled but the boxes had the wrong name.
‘Since these batches were manufactured in 2007 there is likelihood that a number of patients have already been affected. We are monitoring the recall and will continue until all cartons are returned. We hope that the drug companies can be much more careful with issues of quality and not put the lives of patients at risk,’ said Tshabalala-Msimang.
AZT batch number 1J expiring in January 2009 and Nevirapine batch number 1Z expiring in November 2008 has been recalled. ‘ health-e news service