EU Drug Regulator Recalls AIDS Drug Over Contamination Fears
Posted by pozlife on June 8, 2007
by The Associated Press
Posted: June 7, 2007 – 7:00 pm ET
(Zurich, Switzerland) Europe’s drug regulating body is recalling an HIV treatment made by Roche Holding AG because of contamination.
“Contamination has been identified at the manufacturing stage…the steps taken to recall Viracept go down to the level of the individual patient,” said Michael Harvey, a spokesman for the European Medicines Agency.
Patients taking Viracept _ an antiretroviral agent for use in HIV therapy _ should return the treatment to their physician and request a replacement therapy, Harvey said.
The recall does not affect the use of Viracept in the U.S., where Pfizer Inc. (PFE) sells the drug, or Canada and Japan, Roche said.
The Swiss pharmaceutical company conducted a chemical analysis on the drug after six patients reported that their batches of Viracept emitted strange odors.
“A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulphonic acid ethylester,” the company said.
Roche said in a statement that it is recalling all batches of Viracept in co-operation with the European watchdog and Swissmedic, Switzerland’s drug regulator, in Europe and in some undisclosed countries.
Roche said the financial impact of the recall is negligible.
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