Epilim® (sodium valproate) for the treatment of patients with Epilepsy and Bipolar Mood Disorder
Valproate: New safety message in male patients
Please find an update (March 2023) on the safety of valproate – risk to children after paternal use of valproate – in the form of a DHCP letter, here (also found in the HSA website).
Valproate: updates to the HCP and patient guides
This is a reminder on the important safety information with regards to the use of Epilim (Sodium Valproate), and the corresponding Valproate HCP and Patient Guides, which is in accordance with the Epilim® prescribing information that had been approved by the Health Sciences Authority (HSA), Singapore, available on the HSA website.
Information related to the risks of abnormal pregnancy outcomes in children exposed to valproate in utero, with new information on the risk of hearing impairment or deafness, updates related to the risk of ADHD have been included in these guides.
For more details on the information on valproate as mentioned, please refer to the following documents.
• Annual Risk Assessment Form
The above documents will be updated as per the new guidance soon.
Call for reporting
Any suspected adverse events should be reported to the Health Sciences Authority (HSA), Singapore via the online adverse event reporting form available at https://www.hsa.gov.sg/
Company contact point
Adverse drug reactions should also be reported to Sanofi-Aventis (Singapore) Pte Ltd, pharmacovigilance mailbox PV.SIN@sanofi.com.
For further medical information on Epilim®, please contact Sanofi-Aventis (Singapore) Pte Ltd medical enquiry mailbox Med.SAMS@sanofi.com with the subject title “EPILIM”.