Drug company, Roche, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA) issued alerts tonight recalling all batches of the protease inhibitor, nelfinavir (Viracept) following contamination with a genotoxic substance. Patients who are currently taking nelfinavir are advised to contact their doctor immediately in order to switch to another appropriate antiretroviral drug.
A press release from Roche says that the recall affects “Europe and some other world regions” but not the United States, Canada and Japan. It adds that Roche has “received several reports that some batches of Viracept 250mg tablets have a strange odour. A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester. In the interest of patients safety Roche has decided to recall all batches of Viracept tablets and powder.”
A spokeswoman for Roche told BBC Online that the contamination did not appear to be deliberate.
The MHRA Class I Drug Alert (which can be found here) notes: “Patients should be advised to contact their clinic immediately to arrange for provision of an appropriate alternative to Viracept to include in their HIV treatment regimen...We are informed that the contamination affected the active ingredient which was later used in all the presentations. Early tests indicate that the level of contamination may vary between products and batches but we believe patient safety is best addressed by recalling all remaining stock.”