[Viva] Fwd: CATIE News - Trace contaminant found in some batches of darunavir (Prezista)

[Denise Becker]

---------- Forwarded message ----------
From: <mailing at mercury.catie.ca>
Date: Mon, May 16, 2011 at 12:04 PM
Subject: CATIE News - Trace contaminant found in some batches of darunavir
(Prezista)
To: dbecker106 at gmail.com


*CATIE News - Trace contaminant found in some batches of darunavir
(Prezista)*

Janssen-Cilag International, the manufacturer of the anti-HIV protease
inhibitor darunavir (Prezista), has announced that it is working with Health
Canada and regulatory authorities in the European Union to deal with trace
amounts of a contaminant called TBA (known under the chemical name 2,4,6
tribromoanisole) in certain batches of Prezista. An investigation  by
Janssen began after four customers complained of an unusual odour—which they
described as being musty and mouldy—associated with their supply of
Prezista. This resulted in nausea and gastrointestinal symptoms.

The corporation disclosed that in affected EU countries (specifically
Austria, Germany, Ireland and the UK) it has been recalling contaminated
batches from pharmacies and warehouses. At press time, Canadian authorities
had not finalized a course of action. There are less than 300 bottles of
contaminated Prezista in Canada. Fortunately, the contamination is  not
considered sufficiently serious to cause hospitalization. Contamination is
thought to have occurred because wooden pallets containing TBA were used to
move Prezista bottles to the factory. The corporation no longer uses these
pallets.

In Canada, bottles containing 600-mg tablets of Prezista with the lot number
ALZ0J00 were affected. According to Janssen-Cilag, anyone whose Prezista has
an unusual odour should not stop taking Prezista and is instead encouraged
to contact the corporation at 800.567.3331.

*—Sean R. Hosein*



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