The Health Sciences Authority would like to update healthcare professionals on the phasing-out of serratiopeptidase-containing products as medicinal products.
The Health Sciences Authority has conducted a re-evaluation of the risk-benefit profile of serratiopeptidase for its current approved indications. The re-evaluation was undertaken following the voluntary recall of Danzen (serratiopeptidase) Tablets in Japan in February 2011 by its proprietor, Takeda, as recent clinical studies conducted by the proprietor failed to show statistically significant differences between serratiopeptidase and placebo with respect to its efficacy as an expectorant and anti-inflammatory agent. HSA’s review had also taken into account published data provided by other product licence holders. However, these data could not provide further evidence to support the drug’s efficacy due to limitation in study design and methodology.
Based on the available clinical data, HSA’s present evaluation concluded that there is no substantive scientific evidence to support a favourable risk-benefit profile of the use of serratiopeptidase as a medicinal product.
Regulatory action and advisory to Healthcare professionals:
On this basis, HSA will phase out serratiopeptidase products as medicinal products. Considering the long history of use in Singapore with minimal safety concerns, the phase-out process will follow a gradual approach to ensure that immediate impact on patients and stakeholders is minimized. With this, currently registered products will be allowed to continue their marketing authorization until the respective product licence expires.
The Health Sciences Authority has conducted a re-evaluation of the risk-benefit profile of serratiopeptidase for its current approved indications. The re-evaluation was undertaken following the voluntary recall of Danzen (serratiopeptidase) Tablets in Japan in February 2011 by its proprietor, Takeda, as recent clinical studies conducted by the proprietor failed to show statistically significant differences between serratiopeptidase and placebo with respect to its efficacy as an expectorant and anti-inflammatory agent. HSA’s review had also taken into account published data provided by other product licence holders. However, these data could not provide further evidence to support the drug’s efficacy due to limitation in study design and methodology.
Based on the available clinical data, HSA’s present evaluation concluded that there is no substantive scientific evidence to support a favourable risk-benefit profile of the use of serratiopeptidase as a medicinal product.
Regulatory action and advisory to Healthcare professionals:
On this basis, HSA will phase out serratiopeptidase products as medicinal products. Considering the long history of use in Singapore with minimal safety concerns, the phase-out process will follow a gradual approach to ensure that immediate impact on patients and stakeholders is minimized. With this, currently registered products will be allowed to continue their marketing authorization until the respective product licence expires.
There are currently 10 serratiopeptidase preparations registered as medicinal product in Singapore. Details of the specific product and the validity period of the respective product licence can be found on the HSA website, the last product licence will expire in November 2012. Consequently, serratiopeptidase will be phased out as a medicinal product in Singapore and healthcare professionals should consider alternative drug treatment as appropriate.
Pharmaceuticals and Biologics Branch
Health Products Regulation Group
Health Sciences Authority
Health Products Regulation Group
Health Sciences Authority
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