SAFETY ALERT: DARUNAVIR (PREZISTA TM)

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June 6, 2011 – The Pharmacovigilance Program at the BC Centre for Excellence in HIV/AIDS has reviewed the following incident: On May 11, 2011, Janssen Inc. issued an advisory that some bottles of darunavir (Prezista TM) 600 mg tablets in Lot # ALZ0J00 might have an uncharacteristic “musty” or “mouldy” odour caused by trace quantities of the wood preservative by-product 2,4,6,tribromoanisole (TBA).

Health Canada has advised the manufacturer that a product recall is NOT REQUIRED because there is no known safety risk associated with the odour-causing agent. Persons who take darunavir should continue to take their medication. Based on available information, the affected batch of darunavir tablets is safe for consumption and there is no requirement to return product or recall patients for clinical assessment. As a precautionary measure, darunavir tablets from Lot # ALZ0J00, or any darunavir tablets with an uncharacteristic odour that were dispensed in BC may be voluntarily returned to St Paul’s Hospital Ambulatory Pharmacy and exchanged for new product.

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Canada Post has provided notification of restarting their operations on December 17, 2024. As Canada Post ramps up and stabilizes their services, the BC-CfE will continue the following measures on an interim basis to minimize service disruption to BC-CfE clients and providers.

  • The BC-CfE Laboratory will utilize private courier for delivery of outgoing reports and documents. (Lab Contact Information: Phone 604-806-8775; FAX 604-806-9463)
  • The BC-CfE Drug Treatment Program (DTP) will fax outgoing forms and documents to the provider’s office. (DTP Contact Information: Phone 604-806-8515; FAX 604-806-9044)
  • St. Paul’s Hospital Ambulatory Pharmacy will utilize private courier for delivery of medications. (Contact Information: Phone 1-800-547-3622; FAX 604-806-8675)

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