No increased risk of developing cancer for patients having taken Viracept® contaminated with ethyl mesilate

Viracept® is an antiviral medicine, which is used in combination with other antiviral medicines to treat adults, adolescents and children over three years of age who are infected with HIV (human immunodeficiency virus). HIV is the virus that causes AIDS (acquired immune deficiency syndrome).

In June 2007, the European Commission, on the recommendation of the EMEA, suspended the marketing authorisation for Viracept® because some batches of the medicine had become contaminated with ethyl mesilate. Ethyl mesilate is a substance known to be damaging to DNA.

Roche, the marketing authorisation holder, subsequently documented that the manufacturing problems that had led to the contamination had been resolved. In September 2007, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) recommended that Viracept® could be marketed again. As part of this the CHMP also requested Roche to conduct a number of toxicology studies to better assess the potential harm to patients using Viracept® contaminated with ethyl mesilate.

The studies carried out by Roche showed that it is possible to calculate a threshold value below which ethyl mesilate does not cause any irreversible damage (mutations) in the DNA. The CHMP noted that patients or children born to mothers who had taken contaminated Viracept® were exposed to ethyl mesilate levels well below this threshold, and therefore that there was no increased risk of developing cancer for these patients compared with those patients who were not exposed to the contaminant.

The CHMP therefore concluded that there was no need to monitor patients who had been exposed to high levels of contaminated Viracept® through specific patient registries.

For further information, please contact Head of Department Steen Kristensen, tel. +45 4488 9369.

Danish Medicines Agency, 24 July 2008