Date: February 21, 2011
Source: Takeda Pharmaceutical Company Limited
Link: www.takeda.com/press/article_40162.html
Osaka, Japan, February 21, 2011 – Takeda
Pharmaceutical Company Limited (“Takeda”) announced today 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.
Background of Studies
The current indications* of the product were
approved in 1995, based on the results of reevaluation as announced by the then
Ministry of Health and Welfare, on the conditions that the required data at
that time would be prepared before the next reevaluation. Takeda therefore
conducted specific clinical trials: one trial included patients with chronic
bronchitis (protocol: TSP/CCT-901) and two were conducted with patients with
sprained ankle (protocol: TSP/CCT-902, CCT-910). The results were submitted to
the MHLW which are available on the website of The Japan Pharmaceutical
Information Center (JAPIC). http://www.clinicaltrials.jp/user/ctiMenu.jsp
* *
Currently approved indications of Dasen
* •Remission of swelling in the following
diseases or symptoms:
* After operation and trauma, chronic
sinusitis, galactostasis (in cases where breast massage or pumping is
performed)
* •Difficulty of expectoration in the
following diseases with hard-to-eliminate sputum and frequent hacking:
* Bronchitis, pulmonary tuberculosis, bronchial
asthma
* •Difficulty of expectoration after
anaesthesia
About Takeda
Located in Osaka, Japan, Takeda is a research-based
global company with its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for patients worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
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