The Medicines and Healthcare products Regulatory Agency has tightened the regulations on the prescribing of valproate to reduce babies’ exposure to the drug’s serious side-effects during pregnancy and lessen the risk of impaired fertility in men.

The regulator said that from January next year, valproate, which is used to treat epilepsy and bipolar disorder, must not be prescribed to new male or female patients under the age of 55 unless there is no other effective or tolerated treatment as determined by two independent specialists or there are “compelling reasons that the reproductive risks do not apply.”

The MHRA stressed there are other effective treatment options available for the majority of patients. It also said all women who could become pregnant and girls who are taking valproate will be reviewed at their next annual specialist review with a “revised valproate Annual Risk Acknowledgement Form.”

If it is decided that the patient will continue to use valproate, “a second opinion’s signature” will be needed on the form. The MHRA said a similar system will be introduced next year for men who take valproate.

The new measures were introduced after an independent expert group of the Commission on Human Medicines which contained representatives from across the healthcare system recommended they should be phased in to ensure ongoing patient care is not disrupted.

The MHRA said clinicians should discuss treatment plans with patients, including current warnings as well as the new measures on valproate and urged patients to talk to a healthcare professional if they have any concerns.

“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,” said the MHRA’s chief safety officer Dr Alison Cave.

“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.

“If you are a patient on valproate, we ask you to attend any appointments offered over the next year to discuss your treatment plan. Please talk to a healthcare professional if you are concerned. No one should stop taking valproate without advice from their specialist.”

This story was originally published by Independent Community Pharmacist