Pfizer issue Dear Doctor letter over EMS content in US formulation of nelfinavir

3 September 2007. Related: Treatment alerts.

Following the EMS contamination of nelfinavir manufactured by Roche, the FDA required Pfizer, who manufacture and market nelfinavir in the US, to carry out a similar safety analysis.

They reported that the levels of EMS detected in Pfizer’s nelfinavir were much lower than in the contaminated nelfinavir manufactured by Roche.

The FDA and Pfizer have agreed to specific limits of exposure of EMS to allow for continued use in populations where the benefit of using Viracept outweighs the potential risk.

At this time, FDA and Pfizer consider the risks of unintended interruption of HIV treatment that may result from a recall to be greater than the risks associated with taking Pfizer manufactured Viracept.

On 10 September 2007,Pfizer is issued a Dear Healthcare Professional letter to describe the current situation:

http://www.pfizer.com/files/products/viracept_letter_9_10_2007.pdf

Source: FDA list serve