Contamination! AIDS Drug Recalled - July 23, 2007

Roche Pharmaceuticals last month announced a global recall of its HIV/AIDS drug Viracept after discovering that some batches had been contaminated with a carcinogen during a flawed manufacturing process at its Swiss plant.

Tens of thousands of people take Viracept worldwide, most of them poor people with the acquired immune deficiency syndrome in developing countries.

A spokeswoman for Roche said the contaminant, ethyl mesilate, should be called an "impurity" rather than a contaminant because it was created in the manufacturing process and because this type of chemical can be found in very low levels in other medicines, although it was not supposed to be present in Viracept.

At high doses, ethyl mesilate has been shown to cause cancer in animals, and at lower levels it has caused genetic mutations, but data are extremely limited.

It is particularly harmful to children and pregnant women.

Impurity or contaminant – it’s a GMP problem!

Training Tip
In your GMP training sessions, discuss the impact of issues like this on poor people in developing countries. They have enough challenges in life, and this just compounds their struggle to exist.

Read the entire article published in the New York Times on July 23. Go to:
www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down.


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