The medicines regulator has warned healthcare organisations to get ready for new tightened rules on prescribing of valproate that will come into force in the New Year.
From January, the epilepsy drug must not be started in new patients – male or female – under the age of 55 years unless two specialists have agreed and documented there are no other effective or tolerated treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) said for most patients other effective options are available.
In addition, all women who could become pregnant and girls will be reviewed at their next annual specialist check up using a revised risk assessment form which will also need a second signature if the patient is to continue taking valproate, the MHRA said.
Similar steps will be introduced later in the year for men currently taking the medicine, the regulator confirmed.
It comes after recommendations from the Commission on Human Medicines (CHM) a year ago for more scrutiny of prescribing of the drug to ensure it is only used when the benefits outweigh the risks.
Patients should attend all appointments offered to discuss their treatment and talk to a healthcare professional if they have concerns, the MHRA said but no one should stop taking the medicine without speaking to a healthcare professional.
It has been estimated that one in nine babies exposed to valproate during pregnancy will be born with a major birth defect, and as many as four in 10 with a neurological disorder including autism.
The CHM also found a possible risk of impaired fertility in men, which is thought to be reversible on reducing dose or stopping the drug.
The changes have been made in response to concerns that current rules on prescribing of valproate are not being followed despite the known risks.
Earlier this year NHS England created a new tool to help patients understand the benefits and harms of taking valproate.
Dr Alison Cave, MHRA chief safety officer said: ‘Valproate use in pregnancy carries significant risk of harm to the unborn child and should only be used in girls and women of child-bearing potential if a pregnancy prevention programme is in place. It also carries a risk of impaired fertility in males.
‘To better protect patients from these harms, we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing. Valproate should only be used when no other treatment is effective.’
Professor Munir Pirmohamed, Chair of the CHM said he was pleased to see their recommendations were being put into practice.
‘Valproate is a highly teratogenic medicine that also carries known risks to male fertility – it is therefore vital valproate is only used when there is no other effective or tolerated treatment option.
‘We have consulted with patients and healthcare professionals with experience of valproate to inform our recommendations and to ensure that they are introduced in a way that does not disrupt ongoing patient care.’
