Roche's Viracept Recalled; Pfizer's U.S. Version Okay
June 7, 2007
By Tim Horn
(AIDSmeds.com) - Roche, the manufacturer of Viracept® (nelfinavir) in all countries other than the United States (including its territories and possessions), Canada, and Japan, has recalled the 250mg tablet and powder formulation of the protease inhibitor due to chemical impurity. The recall does not apply to the 625mg or 250mg Viracept formulations manufactured by Pfizer for distribution in the United States, Canada, and Japan.
According to a June 6 press release from Roche, the company “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.”
The Medicines and Healthcare Products Regulatory Agency (MHRA), in conjunction with the European Medicines Agency (EMEA), is advising patients in countries where Roche's Viracept is used “to contact their clinic immediately to arrange for provision of an appropriate alternative to Viracept to include in their HIV treatment regimen.”
Source:
Roche, Medicines and Healthcare Products Regulatory Agency (MHRA), and the European Medicines Agency (EMEA).
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