PMSB/SD Notification No. 119 August 16, 2001 To: Mr. Anthony Wynn Representative Director & President Bayer Yakuhin KK To: Mr. Kunio Takeda Representative Director & President Takeda Yakuhin Kogyo KK From: Director Safety Division Pharmaceutical and Medical Safety Bureau, MHLW Enforcement of safety measures in relations with Cerivastatin sodium products 　　　Recently, Cerivastatin sodium products have been recalled voluntarily. The reason is those products were reported to cause rhabdomyolysis even without co-medicated with gemfibrozil (a product not yet approved in Japan, but used widely abroad). Therefore, the Pharmaceutical and Medical Safety Bureau consider that the safety measures described below should be taken immediately targeting medical institutions and pharmacies by supplying appropriate information and actions as necessary. 　　　 Contents 1. Information should be provided for the reasons for voluntarily recall and about the current situation in US and Europe. 2. Rationale should be provided explaining why the products are not recalled in Japan. 3. Data regarding the dose and dosage of, precautions in patients with renal dysfunction, concomitant therapy with fibrate preparations, use in elderly patients, etc. should be provided. 　　　From the other side, gemfibrozil - a fibrate preparation, while not yet approved domestically cannot be denied that can be used by individuals by receiving from abroad, traveling overseas, etc. Therefore, a warning should be made for the risk of prescribing or taking Cerivastatin sodium as a co- medication. Source: Ministry of Health, Labor and Welfare. Translation: JKS LLC The translation, formatting, indexing and hyperlinking of the text are copyrights of the Jouhou Koukai Services LLC Worldwide Copyright (c) 2001-2003 by JKS LLC Reproduction in whole or part without permission is forbidden. www.jouhoukoukai.com PMSB/SD Notification No. 119/August 16, 2001 Japan Regulations Series Copyright (c) 2001-2003 by JKS LLC Page 1 of 2