Pharmaceutical company Adcock Ingram urgently recalled two batches of its antiretroviral products on Friday due to a packaging error.
It asked that Adco-Nevirapine tablets, with the batch number 1J and expiry date January 2009, and Adco-Zidovudine tablets, batch number 1Z and expiry date November 2008, be returned ”without delay”.
This is because certain blisters of Adco-Nevirapine tablets were packed in certain Adco-Zidovudine tablet cartons.
Nine cartons were affected, according to Adcock Ingram executive Kuben Pillay.
The company asked those using the tablets described above to consult their healthcare professionals and not use their discretion.
It said it is preferable to visit the physician treating the patient, but any other qualified medical doctor will be able to help. The patient must take the blister pack, not individual tablets, to the physician.
If nevirapine was dispensed inadvertently, the most common side effects are a skin rash, nausea, abdominal pain, diarrhoea, headaches and fatigue.
A short inadvertent exposure to nevirapine might render the individual resistant to nevirapine, therefore eliminating nevirapine as a future treatment option, according to Pillay. This is because ”single point mutations in the human immunodeficiency virus render drugs like nevirapine ineffective in controlling viral replication”.
No patients have reported any side effects so far, the company said.
Further queries can be directed to Tel: 0860 232 625 or [email protected].
The company said the affected Adco-Zidovudine tablet cartons also reflect the Adco-Nevirapine batch number 1J and expiry date of January 2009.
Therefore, even though the outside carton is labelled as containing Adco-Zidovudine tablets, Adco-Nevirapine tablet blister packs may be in the carton. The blisters (the strip that holds the tablets) are clearly labelled accordingly.
Adco-Zidovudine tablets with a batch number 1Z and expiry date November 2008 are also being recalled as a precautionary measure.
”Adcock Ingram … deeply regrets the error,” the company said.
Antiretrovirals are used as part of the management of HIV/Aids.
According to the Department of Health’s website, the Antenatal Survey Report for 2006 estimated HIV prevalence in the general population to be 5,4-million.
In June the department awarded a tender worth R3,615-billion over two years for the procurement of antiretroviral drugs. Adcock Ingram, which launched its range of three generic antiretrovirals in 2007, was awarded 20,9% of that tender.
In a statement announcing the awarding of the tender, the Health Department said the accumulative number of patients initiated on ARVs was more than 478 000 by the end of April 2008.
For years the department weathered a controversy over its apparent reluctance to accept the efficacy of ARVs, in the face of public statements by the Health Minister Manto Tshabalala-Msimang that appeared to favour treatments leaning more towards nutrition.
She argued that ARVs could become less effective if not administered and monitored properly and that they had toxic side effects for some people. — Sapa