Roche agrees to temporary suspension of nelfinavir's (Viracept) European license - updated

The license for nelfinavir (Viracept) has been temporarily suspended by European drug regulatory authorities. The move comes two weeks after it was discovered that batches of the drug were accidentally contaminated with excess amount of a potentially cancer causing agent.

Roche, the manufacturer of nelfinavir announced that following discussions with the European Agency for the Evaluation of Medicinal Products (EMEA), it had agreed to a temporary suspension of the European approval for its protease inhibitor.

Nelfinavir is currently the subject of a Europe-wide class-one recall. The recall was issued after it was discovered that certain batches of the drug had been contaminated with excess levels of ethyl mesylate, a substance used in the production of the drug. Animal studies showed that large amounts of the substance could cause tumours in rats. It is thought that contamination occurred in late 2006. However, it also appears that lower-levels of contamination may have affected batches of the drug manufactured before this.

Roche is reassuring patients that, in the “worst case scenario” a person taking the contaminated batches would have taken 100 fold less than the amount that caused tumours in rats.

Although the recall was initially thought only to affect Europe, it has subsequently been established that the contamination could affect batches of the drug in every country in the world, with the exception of the Canada, Japan and the US.

A registry of patients potentially exposed to contaminated batches of nelfinavir is to be established by Roche. This will help determine how many patients, if any, suffered ill-effects as a result of the contamination. All patients treated with batches of nelfinavir released after March 2007 will be entered onto the register, as will all pregnant women and children (including those exposed to the drug in the womb) who ever received the drug.

Patients taking nelfinavir must contact their clinic, if they have not already done so, and obtain an alternative anti-HIV drug. Patients are being asked to return any nelfinavir still in their possession to their HIV clinic.

A questions and answers briefing sheet on the recall has been issued by the EMEA. It can be read here.