14 July 2010
The Department of Health (DH) today (July 14) highlighted the risk of severe liver injury with a drug called Arava (containing leflunomide), which is used to treat rheumatoid arthritis.
It was noted through the department's drug surveillance scheme that the Food and Drug Administration (FDA) in the United States announced on July 13 (US time) that information on severe liver injury would be added to the Boxed Warning of Arava (containing leflunomide) to draw attention to such a risk in patients using this drug.
FDA's move was based on their review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In the review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease.
In Hong Kong, drugs containing leflunomide can only be sold in dispensaries on a doctor's prescription and under the supervision of a pharmacist. Arava is registered by Sanofi-Aventis Hong Kong Limited and information on severe liver injury is already carried in its package insert.
In addition, there are two brands of products containing leflunomide available in Hong Kong, "Apo-leflunomide" and "PMS-leflunomide". The surveillance finding will be referred to the Registration Committee of the Pharmacy and Poisons Board which will review the registration requirements for these products in its next meeting.
A DH spokesman advised members of the public using leflunomide to consult their healthcare professionals should they have any concerns.