New rules over drug dubbed ‘new thalidomide’ after medication shown to cause birth defects in babies
A DRUG dubbed the “new thalidomide” will face stronger restrictions from January, regulators have announced.
Valproate — an epilepsy drug that has been linked to birth defects — will no longer be offered to new patients under 55 unless no other treatment is effective.
The Medicines & Healthcare products Regulatory Agency announced the changes, with new prescriptions only to be offered if two doctors sign off on them or “reproductive risks do not apply”.
It is the first time the drug has been restricted for men and boys, who could have their fertility impacted by it, research shows.
Dr Alison Cave, of the MHRA, 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.
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“To better protect patients from these harms, we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing.”
She added: “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.”
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Around 625,800 Brits have epilepsy — a condition that affects the brain and causes regular seizures.
Treatments can help people have fewer seizures or stop them completely, with anti-epileptic drugs like valproate often prescribed by doctors.
However, research has shown the drug can also cause birth defects when taken by pregnant women.
The MHRA ruled the drug should no longer be prescribed to women of “childbearing potential” in 2018 because of the risk.
Valproate use in pregnancy carries significant risk of harm to the unborn child
Dr Alison Cave, MHRA
Analysis earlier this year showed it was prescribed to too many women in a “bigger scandal than thalidomide”, according to Henrietta Hughes, patient safety commissioner for England.
Separate studies have also shown the children of men who take it could be at increased risk of having disabilities.
Now, the MHRA has changed the guidance to mean fewer men and women under the age of 55 will receive it.
Health minister Maria Caulfield said: “We are focused on improving how the system listens to patients and healthcare professionals, and our sympathies remain with all those affected by the side effects of sodium valproate.
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“These regulatory measures will help to further improve patient safety and ensure valproate is only used when the benefits outweigh the risk.
“I’d encourage anyone affected or concerned to speak with a healthcare professional, including to get further information about the other effective medicines to treat epilepsy and bipolar disorder.”