EU regulator recalls Roche’s anti-HIV drug on contamination fears
Europe’s drug regulating body on Wednesday recalled an HIV treatment made by Roche Holding because of contamination.
By Agencies |
ZURICH: Europe’s drug regulating body on Wednesday recalled an HIV treatment made by Roche Holding 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 US, 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 odour.
“A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester,” the company said.
Roche said in a statement that it is recalling all batches of Viracept in cooperation 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. “The financial impact of this recall isn’t material to the company,” said Daniel Piller, a spokesman for Basel-based Roche.
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 US, 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 odour.
“A detailed chemical analysis of the affected tablets showed they contain higher than normal levels of methane sulfonic acid ethylester,” the company said.
Roche said in a statement that it is recalling all batches of Viracept in cooperation 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. “The financial impact of this recall isn’t material to the company,” said Daniel Piller, a spokesman for Basel-based Roche.
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