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The Department of Health (DH) today (November 23) instructs the recall of an imported cancer drug Vidaza for Inj. 100mg (registration no.: HK-55407, Vidaza) and alerts healthcare professionals on quality issues of another four imported cancer drugs Bicnu for Inj. 100mg (registration no.: HK-05144), Busulfex Inj. 6mg/ml (registration no.: HK-50627), Caelyx Conc for Infusion 2mg/ml (registration no.: HK-43397) and Velcade for Inj. 3.5mg (registration no.: HK-53329) because of shortcomings found in the quality management system of Ben Venue Laboratories' (Ben Venue) manufacturing site in Ohio USA.
The DH, through its ongoing drug surveillance scheme, learned that a joint Good Manufacturing Practice (GMP) inspection by European and US medicines regulatory agencies in early November this year had discovered shortcomings in quality management system, particularly in relation to the aseptic filling process, in the North Complex of the Ben Venue facility. Ben Venue had decided to cease all manufacture and distribution of medicines from the site as a precautionary measure and to investigate the GMP issues identified.
In Hong Kong, there are 13 registered pharmaceutical products (product list at Annex) manufactured by Ben Venue. Seven products had been imported to Hong Kong. Among these seven products, there is no remaining stock of Neurolite for Inj with Buffer Vial (registration no.: HK-43086, Neurolite) and Cardiolite for Inj (registration no.: HK-43085). Neurolite had previously been recalled in September 2011.
Vidaza was manufactured by Ben Venue and Baxter Oncology GmbH in Germany. As the problem affects Ben Venue, only Vidaza manufactured by Ben Venue is recalled.
Vidaza was imported by Jacobson Medical (Hong Kong) Limited (Jacobson), a licensed drug wholesaler. The record shows that a total of 1,144 vials had been imported into Hong Kong in 2011. They were distributed to the Hospital Authority, private hospitals, private practitioners and pharmacies. Jacobson has set up a hotline (Tel: 28171616) to answer related enquiries. The DH will monitor the recall.
The rest of the imported products, namely Bicnu for Inj. 100mg, Busulfex Inj. 6mg/ml, Caelyx Conc for Infusion 2mg/ml and Velcade for Inj. 3.5mg are currently available here.
The spokesman said, "As there are no alternatives to replace the use of these four drugs in the market and these drugs are considered to be essential to meet patients' needs, healthcare providers are advised to weigh the benefits against the potential risk when they consider to continue the treatment for existing patients. However, no new patients should be started on treatment. They should monitor intensively patients on these four drugs and report any adverse drug reactions and relevant safety concerns, such as sepsis."
"So far, the DH has not received any adverse reaction report related to the incident."
The DH has issued letters to healthcare professionals, the Hospital Authority, private hospitals, and healthcare professional bodies. DH will contact overseas regulatory authorities for further information and follow-up the investigation.
Ends/Wednesday, November 23, 2011
Issued at HKT 22:59
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