Sodium Valproate Agreement

Information on the risks of taking valproate during pregnancy. If you or your child are affected by valproate medications, you can also contact a support network such as: British Paediatric Neurology Association (BPNA) and the Royal College of Paediatrics and Child Health (RCPCH) – Common advice for making recommendations on the use of valproate in patients under the age of 18. On March 21, 2018, CMDh1 approved new measures to prevent babies from being exposed to valproate-based drugs in the womb, with babies exposed at high risk of malformations and developmental problems. All women and girls who are prescribed valproate should consult their family doctor and have their treatment checked. The measurements are based on a review of available scientific knowledge, including studies on drug use and clinical and laboratory evidence of the drug`s effects. During the review, pragC also consulted extensive consultations with health professionals and patients, including women and their children, who were victims of valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including health professionals) , patient associations, patients and their families) and a public hearing. Valproate (Epilime, D├ępakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women taking valproate during pregnancy. The active ingredient in these drugs may be valproic acid, magnesium valproate, sodium valproate, valproate-half-sodium or valpromide. A new video for health professionals, which covers the use of valproate by women and girls, has been added. It is important that women do not stop taking valproate without talking to their doctor beforehand.

Taking valproate during pregnancy presents a significant risk of birth defects and developmental disorders. Companies that market these drugs are also required to conduct further studies on the nature and extent of risks and to monitor valproate use and the long-term effects of affected pregnancies. The Pregnancy Prevention Program applies to all women of childbearing age who are taking a drug containing valproate. The only exception is when the specialist believes that there is no risk of pregnancy. For example, before menarche or post-menopausal. If you have any questions or concerns about the risks associated with valproate and pregnancy, talk to your doctor, pharmacist or other health care professional. The following resources are available to help health professionals understand their clinical responsibility for valproate: CMDh has agreed to the EMA`s Pharmacovigilance Risk Assessment Committee (PRAC), which conducted a review and recommended that women still not receive the right information despite previous recommendations to better inform patients about the risks associated with these drugs. The new measures approved by the CMDh therefore reinforce pre-valproate restrictions and women`s risk reporting requirements. We observed trends in sodium valproate prescribing to assess the impact of current regulatory recommendations and the introduction of the pregnancy prevention program using primary supply data from the Clinical Practice Research GOLD database.

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