Australian Information on Valproate
When used just prior to becoming pregnant or during pregnancy, valproate is known to cause major physical birth abnormalities in 11% of children and neurodevelopmental delay or disability in 30-40% of children.
Consumer information available in Australia about valproate is very limited. There are three documents written for consumers and all are very are difficult to find online (links are provided below).
There is a reliance by regulatory authorities on all doctors providing complete information and adequate opportunity to question the information prior to prescribing; it is known that patients are frequently not fully informed. It is known that patients are frequently not fully informed of the risks versus benefits of valproate. (linked 2/12/2024)
It is also presumed the TGA product information is known and followed by all doctors; this assumption cannot be made, particularly where clinical practice guidelines and known common use are inconsistent with the PI.
To make informed decisions, especially about high-risk medications, it is not sufficient to assume doctors will provide all necessary information to patients; patients need independent access to reliable information. You are encouraged to review any information you obtain with your doctor and discuss the details with your people you involve in your healthcare. This will help ensure you can make the best healthcare choices for your situation.
PATIENT GUIDE FOR FEMALES BY BIRTH
The TGA requires Sanofi to produce a booklet with information for patients that must be kept current according to latest research outcomes.
Linked 30/11/2024
PATIENT GUIDE FOR MALES BY BIRTH
More information is emerging about the possible link between male use of valproate and children born with neurodevelopmetal delay or disability.
Linked 30/11/2024
Booklets with important information written by the manufacturer of Epilim
Information Booklets
HEALTH CARE PROVIDER INFORMATION
The TGA requires Sanofi to produce a booklet with specific information for prescribers and pharmacists that is kept up to date with current research.
Linked 30/11/2024
CONSUMER MEDICINE INFORMATION (CMI)
Consumer medicine information contains information the pharmaceutical company considers relevant for consumers and is written in plain English. It is not assessed by the TGA. (Linked 2/12/2024) The CMI explains the uses of the medicine, possible side effects and what you need to know before taking it including warnings about when it may need to be reconsidered.
Linked 30/11/2024
PRODUCT INFORMATION (PRESCRIBERS) (PI)
Product information contains clinical information including indications, contraindications, precribing information, pharmacodynamics and other technical information.
Linked 30/11/2024
POSSIBLE LINK BETWEEN MALE USE OF VALPROATE WITH BIRTH ABNORMALITIES
There is new and early research linking a higher rate of disabilities of children to the use of valproate by fathers in the weeks preceding conception.
Linked 2/12/2024
Standard information sheets for consumers and healthcare professionals in the same format as all medicines registered with the TGA. These are consistent with, but not the same as the booklet information. Consumers should read the consumer information sheet in addition to the booklet.
Manufacturer Medicine Information
AUSTRALIAN PREGNANCY REGISTER FOR WOMEN ON ANTIEPILEPTIC MEDICATIONS
A long running clinical research program that contributes to international studies on epilepsy treatment during pregnancy
Linked 9/12/2024
Australian Pregnancy Register
The Royal Melbourne Hospital
PBS LISTING FOR LAMOTRIGINE
(Lamictal and other brands)
Click on "Authority required" red text to see the restrictions for who can pay the PBS price.
Linked 30/11/2024
PBS Information
Current PBS listings - subsidy conditions
ADVISORY COMMITTEE ON MEDICINES 2024 MEETING
Statement on outcome of consideration on restrictions on use of valproate in Australia following additional restrictions applied in the UK
Linked 30/11/2024
ADVISORY COMMITTEE ON MEDICINES 2018 MEETING
Statement on outcome of consideration on restrictions on use of valproate followiing considerable restrictions being implemented in the UK & Europe
Linked 30/11/2024
TGA MEDICINE SAFETY ALERT 2014
Alert to healthcare pofessionals on harms to children when valproate is prescribed to pregnant women
Linked 30/11/2024
MINUTES OF 2024 ADVISORY COMMITTEE ON MEDICINES MEETING
Detailed information on what was considered and the outcomes of the 2024 meeting reviewing the regulation of valproate in Australia
Linked 30/11/2024
TGA Information
Information on recommendations for regulating valproate
CONTACTS FOR AUSTRALIAN INFORMATION
© 2024. All rights reserved.
We pay respect to past and present elders & traditional owners of Dharug Country upon whose land this website is maintained. We honour Indigenous peoples as the first and rightful custodians of country throughout all Australian territory.
Every effort has been made to provide independent information from high quality sources to raise awareness of the dangers of valproate and promote informed consent. No responsibility is taken for any instance where a person relies upon any information or link from this website. Individuals are responsible for their own due diligence. The information on this site is not comprehensive.