The FINANCIAL — Takeda Pharmaceutical Company Limited (“Takeda”) announced on February 21 its decision to voluntarily recall Dasen 5 mg tablets, 10 mg tablets, and 1% granules (generic name: serrapeptase), anti-inflammatory enzyme preparations sold in Japan, starting on February 21.
In the double-blind studies that have been conducted to compare Dasen with placebo ("Studies"), no statistical significant differences were found. Based on the results of the Studies, the Committee on Reevaluation of the Pharmaceutical Affairs and Food Sanitation Council (“Committee”) of the Ministry of Health, Labour and Welfare of Japan (“MHLW”) held a meeting on January 19, 2011 in order to discuss the possibility of categorizing Dasen as the product for the future reevaluation with additional studies to be conducted, including the contents of such studies if that is the case.
As a result, the Committee pointed out the necessity of conducting additional studies in a manner that reflects current clinical treatment practices, and to prove the efficacy of Dasen. In accordance with the instruction of the MHLW, Takeda has been studying the feasibility of conducting such studies. Takeda believes that the efficacy of Dasen would be confirmed through additional clinical trials with a revised study design, however, it has reached a conclusion that it would be difficult to conduct additional studies as requested.
Takeda has been marketing Dasen in Japan since 1968 and the product has been prescribed by physicians to a number of patients for over 40 years. Takeda will ensure that accurate information will be communicated promptly to healthcare providers to minimize confusion in the medical practice or among patients upon recall of the product.
The sales of Dasen in Japan in the 2009 fiscal year were Yen 6.7 billion and the impact of this issue on the fiscal 2010 financial year is estimated to be minimal at this moment.
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