Other safety alerts
|
| |
| The United Kingdom: Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures |
| |
The Medicnes and Healthcare products Regulatory Agency (MHRA) advised that babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30-40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 and February 2016 on the magnitude of this risk and the actions to take, there is evidence that women are still not aware of the risk. Patient Safety Alerts have now been issued asking all organisations to undertake systematic identification of women and girls taking valproate. A new European review is considering whether further regulatory action is necessary and there will be a public hearing at the European Medicines Agency (EMA) later in 2017.
The MHRA’s toolkit resources have been disseminated widely. However, evidence suggests as many as 1 in 5 women taking valproate are not aware of any of its risks in pregnancy. Evidence from the Clinical Practice Research Datalink also suggests that, although prescription rates for valproate have been declining gradually in recent years, the measures put in place have not had a significant effect.
On 6 April 2017, NHS Improvement and MHRA sent a Patient Safety Alert through the NHS Central Alerting System to further highlight risks to the unborn child and support the safety of girls and women taking valproate. Consistent action is being taken in Scotland, Wales, and Northern Ireland. These alerts direct organisations to undertake systematic identification of women and girls taking valproate and to use the MHRA resources to support them to make informed choices.
In March 2017, the European Pharmacovigilance Risk Assessment Committee (PRAC) initiated a further review to look at the use of valproate-containing medicines in women and girls of childbearing potential. The committee will consider whether these medicines require further restrictions of use due to their very high risk of causing developmental disorders and congenital malformations to unborn babies and evidence of continued use in pregnancy. The review will also examine the effectiveness of regulatory measures put in place to increase awareness and reduce valproate use in patients at risk.
The MHRA advised healthcare professionals of the followings:
• do not prescribe valproate medicines for epilepsy or bipolar disorder in women and girls unless other treatments are ineffective or not tolerated; migraine is not a licensed indication
• ensure women and girls taking valproate medicines understand the 30–40% risk of neurodevelopmental disorders and 10% risk of birth defects and are using effective contraception
• valproate use in women and girls of childbearing potential must be initiated and supervised by specialists in the treatment of epilepsy or bipolar disorder
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/valproate-and-developmental-disorders-new-alert-asking-for-patient-review-and-further-consideration-of-risk-minimisation-measures
In Hong Kong, there are 15 registered pharmaceutical products containing valproic acid and/or valproate, and they are prescription only medicines. In December 2014, the Registration Committee of the Pharmacy and Poisons Board discussed the findings of an EMA’s previous review on the risks of valproate products in pregnancy and had decided that warnings and precautions on the risks of pregnancy should be included in valporate products. So far, the Department of Health (DH) has received six cases of adverse drug reactions in connection with valproic acid or valproate, but none of them was related to adverse effects in new-born babies whose mothers took valproate for their medical conditions.
As EMA is conducting a new review on whether further regulatory action is necessary for valproate products, which has been reported on the Drug Office website on 13 March 2017, DH will remain vigilant on the outcome of the review and will continue to monitor safety updates of valproate issued by other overseas drug regulatory authorities.
Ends/Tuesday, April 25, 2017
Issued at HKT 16:00
|
| |
|
