All the meetings, those private talks , all that hard work
New Guidelines for Sodium Valproate have now been put into place
Sodium Valproate - New Advice
Also known as: Epilim, Episenta, Epival and Depakote
Valproate is a medicine prescribed for epilepsy and bipolar disorder. Since its introduction in 1974, the product information for doctors has included a warning about the possible risk of birth defects. There is now a greater understanding of the risks to unborn children and in line with recogniton of this, the warnings have been strengthened.
MHRA has worked with industry, healthcare professionals and patient groups,, such as the Organisation for Anti-Convulsant Syndrome in order to develope a toolkit to ensure female patients are better informed about the risks of taking valproate medicines during pregnancy.
The the risk of developmental disorders is up to 4 in 10
In women who take valproate while pregnant, around 1 in 10 babies will have a birth defect.
Birth defects seen when mothers take valproate during pregnancy include:
spina bifida (where the bones of the spine do not develop properly)
facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
malformations of the limbs, heart, kidney, urinary tract and sexual organs.
In women who take valproate while pregnant, about 3–4 children in every 10 may have developmental problems. The long-term effects are not known.
The effects on development can include:
being late in learning to walk and talk
lower intelligence than other children of the same age
poor speech and language skills
Children exposed to valproate in the womb are more likely to have autism or autistic spectrum disorders. There is also some evidence children may be more likely to be at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).
Valproate should not be used in female children, in female adolescents, in women of childbearing potential and in pregnant women unless other treatments are ineffective or not tolerated. Women of childbearing potential must use effective contraception during treatment.
No-one should stop taking valproate without discussing it first with their doctor and the benefits of valproate treatment must be carefully balanced against the risks.
If valproate is the only option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.
THE NEW SODIUM VALPROATE TOOLKIT FROM THE MHRA (2016):
So many of you took part in the journey to make this happen; from the meeting with Norman Lamb, to parliament, to PRAC and the NHS meeting to develop guidelines in pregnancy.
Further credit is to be given to the professionals we have worked with, including those in the MHRA, EMA, Alec Shelbrook and Norman Lamb.
Feedback given by the OACS members has further supported this process. Each of you that gave their time to this process.
Thank you everyone for this joint effort.
We would also like to thank the pharmacist the GP's, the neurologist, the consultants and other health care professionals that were willing to give their time to discuss their concerns, and possible solutions.
Thank you Everyone!