From Times Online
June 6, 2007
Health alert over HIV drug
HIV sufferers who take the antiretroviral drug, Viracept, should contact their doctors immediately, British health officials said tonight, after the medicine was found to contain a substance that can cause cancer.
The Medicines and Healthcare products Regulatory Agency (MHRA) and European regulators said that batches of Viracept across the EU had been tainted by a “genotoxic” or potentially cancer-causing chemical.
The drug’s manufacturer, Roche, issued a statement saying that Viracept tablets on sale in Europe and across the world had been found to have “a strange odour” and that subsequent tests had shown the presence of methane sulfonic acid ethylester, which is classified as carconogenic by the International Agency for Research on Cancer.
“In the interest of patients safety Roche has decided to recall all batches of Viracept tablets and powder,” the company said, adding that the US, Canada and Japan were not affected by the alert.
In its statement, the MHRA said that it was “alerting health professionals tonight concerning a contamination with a genotoxic substance affecting the production of all batches of the medicine Viracept.”
“The MHRA, in conjunction with the European Medicines Agency (EMEA) and Roche, has issued a drug alert to recall this medicine from the market, to minimise the risk to patients. Patients prescribed Viracept should contact their doctor immediately. They will have to change to another appropriate medicine for their condition.”
“There is a problem in manufacturing,” said a spokesman for the European Medicines Agency explaining the sudden decision.
Viracept, whose generic name is nelfinavir, is a antiretroviral agent used by HIV patients across the world as part of a cocktail of drugs to control the virus. The drug works by lowering the amount of virus in the body (viral load) and slows the progression of the disease from HIV to AIDS.
A type of drug known as a protease inhibitor, it was developed by Agouron Pharmaceuticals in the early 1990s and became popular because it is easy to take with fewer side effects than other drugs of its type. Viracept is sold in the United States by Pfizer and to the rest of the world by Roche. In 2003, Roche agreed to slash its price for sale in sub-Saharan Africa.
A spokeswoman for Roche said the drug was currently being used by about 550 people in the UK. She said there was no indication that the contamination was deliberate.
Roger Pebody, treatment adviser for the Terrence Higgins Trust, said Viracept was in one of the older classes of HIV drugs and was not widely used in the UK now. But he said that missing just one dose could impede its effectiveness and that patients should contact their doctors immediately. â€œThat is putting people under a lot of pressure but you would not want to leave off one or two doses,” he said.