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The Irish medicines regulator has advised patients not to stop taking valproate medicines without consulting a doctor in the wake of new recommendations on the drugs in the UK.

The Health Products Regulatory Authority (HPRA) said they are now taking part in a group examining the use of these medications in Ireland as part of a multi-stakeholder process.

This is led by the Department of Health, the HPRA said.

On Monday, British health authorities announced new recommendation around prescribing of this medication for under-55s although patients were told to take no action yet.

A HPRA spokeswoman said: “The HPRA emphasises that patients should not stop taking valproate-containing medicines without consulting a doctor.

“Sudden discontinuation of any treatment for epilepsy should be avoided as this may lead to seizures that could have serious consequences, including for a pregnant woman and an unborn child.”

The HPRA is a member of the European Medicines Agency safety committee, and follows their recommendations, she said, adding:

The remit of the HPRA does not extend to how these measures are implemented within the health service.

They provide educational materials, she said, for healthcare professionals to ensure awareness of these risks is high. This includes posters for display in pharmacies.

Valproate or sodium valproate is used for treating epilepsy, bipolar disorder and other conditions. Commonly sold in Ireland under the brand name Epilim, it has been shown to carry a high risk of causing life-changing disabilities to babies in the womb if their mother takes this while pregnant.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) completed a data review, and asked for advice from the independent Commission on Human Medicines (CHM).

In a statement on Monday, the MHRA said: “The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment.”

This is based on the risks to babies in the womb from valproate ,and the risks to male fertility for men taking this medication.

Advice to doctors on how these new recommendations can be implemented in the UK is expected.

 

Source: irishexaminer.com, NIAMH GRIFFIN

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