Japan - Ozagrel sodium, a thromboxane synthesis enzyme inhibitor is indicated for the improvement of postoperative cerebrovascular contraction and accompanying cerebral ischaemia and for improvement of motility disturbance due to acute cerebral thrombosis.
In April 1994 and April 1996, abnormal kidney function, increase of BUN, and increase of creatinine were added to the labelling. However, 14 serious cases of acute renal failure have since been reported to the Ministry of Health and Welfare. Manufacturers have accordingly been directed to include "abnormal renal function" in the product labelling.
Reference: Ministry of Health and Welfare (MHW) Pharmaceuticals and Medical Devices Safety Information, No. 162, Tokyo 27 September 2000.