New safety warnings
New measures to avoid valproate exposure in pregnancy
Valproate is a commonly used drug to treat conditions such as epilepsy, bipolar disorders and, in some countries, migraines. However, even though it is a commonly used drug, people are still unaware of the risks valproate presents, especially during pregnancy, with babies at a very high risk of being born with malformations and developmental problems.
Valproate and the effect it has on babies in the womb has been gaining more awareness in the healthcare sector for the past decade or so. However, recent research carried out by epilepsy charities suggests that still one in six users are unaware of the risks that using valproate presents to a foetus.
Regulatory bodies within the healthcare sector, such as the European Medicines Agency, have been put under increasing pressure by campaigners to do more with respect to raising awareness about the dangers of taking valproate while pregnant. This has led to the European Medicines Agency acting, with all member state representatives agreeing to new restrictions and a pregnancy prevention programme.
Under the new restrictions, treating bipolar or migraines with valproate, in pregnant patients, is now banned. Treating pregnant patients suffering from epilepsy with valproate is now also banned unless there is no other alternative treatment available. Also, a warning of the risks to pregnant women must be put on the packaging and warnings must be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
For further information, please visit the European Medicines Agency website.
MHRA update on valproate
The MHRA recently released an update on the use of valproate in women with childbearing potential. The update states that “valproate medicines must not be used in women and girls of childbearing potential unless the conditions of the Pregnancy Prevention Programme are met and only if other treatments are ineffective or not tolerated, as judged by an experienced specialist”.
The Pregnancy Prevention Programme ensures that women who take valproate have been told all the risks that taking the drug has during pregnancy and that they sign a Risk Acknowledgement Form. It also ensures that the women taking valproate are on contraception that is highly effective and they see a specialist at least once a year. If this criteria is not met, then women cannot be prescribed valproate.
In the coming weeks, you should receive information from the MHRA on the Pregnancy Prevention Programme which will include a patient guide, a guide for healthcare professionals, a Risk Acknowledgement Form, a patient card and stickers with warning symbols.
For more information on this MHRA update, please visit their website.
Revised SPC: Efexor (venlafaxine) capsules – all strengths
The Summary of Product Characteristics (SPC) has been revised for all strengths of Efexor (venlafaxine) capsules. The part of the SPC that has been updated is:
“Venlafaxine should be used with caution in patients with MI or unstable heart disease. Post-marketing cases of QTc prolongation, torsade de pointes, ventricular tachycardia, and fatal cardiac arrhythmias have been reported, especially in overdose or in patients with risk factors.”
For more information please visit the SPC website: www.medicines.org.uk/emc/product/5059/smpc