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

May 16, 2011 - 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


From Canadian AIDS Treatment Information Exchange (CATIE). For more information visit CATIE's Information Network at http://www.catie.ca

Source: CATIE: CANADIAN AIDS TREATMENT INFORMATION EXCHANGE


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