Product Safety
Safety Assessment in Korea
A six years (2002-2008) continuous safety monitoring of BTXA™ application was carried out in South Korea [1]. Total 659 cases with blepharospasm, hemifacial spasm and strabismus were studied and the safety of BTXA™ application was evaluated. The respective Periodic Safety Update Report (PSUR) was also submitted to Korean FDA .
- Only 2.58% of patients (17 out of 659) reported have Adverse Events (AE); Overall AE rate is low
- No serious AE or systemic side effects were reported
- All AE cases recovered in 1-4 weeks
Safety Assessment in Brazil
Another post marketing surveillance was carried in Brazil during 2003 to 2008. About 300,000 cases have been treated with BTXA™ .Based on the collected data, less than 1% of cases reported had adverse events which was perfectly within the expected range from international literature.
- Data on file [BTXA Inj. Post Marketing Surveillance Study with Case Report (BTXA INJ. Clostridium Botulinum A Toxin), 28 August 2008], Hugh Source (Int'l) Ltd.
- Data on file [(Drug Safety Report, Prosigne® (Botulinum Toxin Type A), January 2009)],Hugh Source (Int'l) Ltd.
