Roche recalls Viracept over contamination fears

Swiss pharma giant Roche has recalled all batches of Viracept (nelfinavir) in Europe and some other parts of the world as some batches have been shown to contain higher than normal levels of methane sulfonic acid ethylester, which is potentially genotoxic.

Roche has received several reports that some batches of Viracept 250 mg tablets have a strange odour and has decided to recall all batches of Viracept tablets and powder in the interests of patient safety. Roche said contamination had been caused by 'human error'.

A company spokesperson revealed the contaminated batches came out of one of its production plants in Basel, Switzerland. 'We have identified the source of the impurity, which was caused by human error in maintenance of production equipment. We have rectified the situation and are now preparing new batches of Viracept,' she said.

She could not rule out the possibility that some patients may have taken the contaminated drug, but emphasised that risks to patients were small. 'Patients who may have taken tablets from the affected batches are advised to see their HIV doctor to switch therapy to alternative treatments.

'The risk to patients from this impurity is thought to be low. We estimate the highest potential exposure to patients from affected Viracept formulations is 100 fold lower than the dose shown to be harmful to rats.'

The US, Canada and Japan are not affected by the recall.

Viracept is a protease inhibitor first introduced by Roche in 1998. It is licensed for use in combination with other antiretroviral drugs.