Press Release
Warning against contamination in registered Cerezyme and Thyrogen products
16 Nov 2009
The Department of Health (DH) today (November 16) alerted healthcare professionals to thoroughly inspect two registered pharmaceutical products before use in view of the potential for foreign particle contamination.
The products are Cerezyme (registration number HK-46149) and Thyrogen (registration number HK-54932) manufactured by Genzyme Corporation in the U.S.. Cerezyme is used to treat Gaucher disease (a genetic enzyme deficiency disease) while Thyrogen is an adjunctive diagnostic tool and treatment for thyroid cancer.
The alert followed U.S. Food and Drug Administration's warning against the potential for contamination of Genzyme products in the manufacturing process, which could potentially cause serious adverse events in patients.
According to Genzyme, the affected lots carried the prefix "A" (e.g. Lot A12345).
In Hong Kong, these products are registered by Genzyme Asia Limited, and are prescription medications.
A DH spokesman said: "FDA decided to allow continued marketing of the products in view of the critical need for patients to have access to these products and the lack of approved alternatives."
"The DH has not received any reports of adverse drug reactions regarding the usage of Cerezyme and Thyrogen.
"Letters to doctors have been issued by the DH and the drug company respectively. Doctors should discuss with patients the potential contamination, the clinical necessity and the potential risks with untreated illness.
"Patients should seek prompt medical advice for concerns or adverse effects related to the use of the two products. Doctors should report any adverse events to DH at 2319 8482.
"The DH will closely monitor the situation," the spokesman said.
Doctors are advised to reduce the risk of administering a contaminated product by visually inspecting the powder in the vial and the reconstituted powder (in solution) for the presence of particles before use. They should contact Genzyme for problems with the products.
Genzyme has also set up a hotline 9866 6489 for handling enquiries.
