Viracept recalled after fears of genotoxic contamination
All Viracept
(nelfinavir; Roche) products are being recalled following concerns about contamination with a genotoxic substance.
The Medicines and Healthcare products Regulatory Agency is advising patients
prescribed Viracept to contact their clinic immediately to arrange for
provision of an appropriate alternative treatment to include in their
HIV regimen.
The level of contamination appears to vary across products and batches,
but the MHRA insists that patient safety is best addressed by recalling
all remaining stock. “Toxic contaminants are highly undesirable
in any population, but we have special concerns as this drug may be used
in children and pregnant women who are at high risk,” the MHRA
said.
Since boosted protease inhibitors became the standard of care, only a
limited number of HIV-positive patients take nelfinavir as part of their
highly active antiretroviral therapy combination, Brett Marett, principal
pharmacist for HIV and sexual health at St Mary’s NHS Trust Hospital,
London, told The Journal.
However, he added, nelfinavir is currently used as part of HIV post exposure
prophylaxis [PEP] regimens in many centres and so a number of patients
would have been taking nelfinavir for PEP. “They are likely to
be switched to a boosted protease inhibitor with a new spectrum of drug
interactions so clinical vigilance is essential,” he said.
The recall resulted from a series of patient reports of tablets having
a peculiar odour. Analysis of these tablets revealed the presence of
methane sulfonic acid ethyl ester, which is known to be genotoxic.
Roche believes that around 550 patients were taking Viracept when the
recall was initiated but that the risk to patient safety is low, since
the contaminant is present at levels well below those needed to cause
adverse events in animal studies.
Notice-board p701 (PDF 30K)
|
The
Pharmaceutical Journal
Acrobat
Reader