Recall

URGENT MEDICINE RECALL

ALL VIRACEPT FORMULATIONS

Roche has received several reports in Europe that some batches of Viracept tablets have a strange odour.  An analysis of the affected tablets has detected the presence of an impurity called methane sulfonic acid ethyl ester in the active substance.

Accordingly, Roche is recalling all Viracept products from the Australian marketplace, and other overseas markets supplied from the affected manufacturing site, due to possible contamination of the active substance.

The effects of methane sulfonic acid ethyl ester in humans has not been studied; however, research in animals shows that the class of chemical called ‘alcylmesilates’ which includes methane sulfonic acid ethyl ester are mutagenic. 

In assessing the risk to individual patients, it is important to realize that the genetic predisposition of each patient plays a role, as does the amount of the impurity contained in each individual dose of Viracept that was taken.

However,  to give you some risk assessment guidance, it has been estimated that a daily exposure of 10 mg/person for 10 days may induce a tumour in 1 person out of 1 million.  Furthermore we estimate that the highest potential exposure to patients from affected Viracept formulations is 100 fold lower than the dose shown to be harmful to rats. Nevertheless in the interest of the individual patient safety we have decided to recall all possibly affected Viracept formulations. 

Our understanding of the risk posed by the contaminant is evolving.

Download   -  Toxicological _Expert _Statement _EMS.PDF

Roche Products Pty Limited

ABN 70 000 132 865