Letter released to women and girls taking Sodium Valproate

NEWS RELEASE 14/6/21

NHS Issues Advice To Girls And Women Taking Sodium Valproate For Epilepsy

20,000 women and girls will this week be reminded of risks during pregnancy while taking an epilepsy drug, as part of the NHS’s drive to increase patient safety.

Over the coming days letters are being sent to females in England aged between 12 and 55 who are currently recorded as having an active prescription for the drug, Sodium Valproate, outlining a number of actions to take if they are pregnant, trying for a baby or have not had a recent medication review.

Sodium valproate is a drug that can be used to treat epilepsy and bipolar disorder, however babies can be harmed if the person taking the drug becomes pregnant.

The NHS is now sending reminder letters as part of the organisation’s drive to inform patients and prevent future risks.

The letter from the NHS Director of Patient Safety, Dr Aidan Fowler, will urge those with an active prescription to continue their treatment course until their doctor tells them otherwise, but to:

  • Continue to take contraceptive measures, ideally the implant or coil, while they are taking valproate;
  • Speak to their GP immediately if they think they may be pregnant;
  • Seek a medicines review from their GP if they haven’t received one in the last 12 months, and;
  • Speak to their doctor if they are keen to try for a baby, before coming off contraception.

The reminder is part of the NHS’ ongoing response to former health Minister Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review, published last year.

A new data registry has also been established, managed by NHS Digital, to better track prescriptions to women.

NHS Patient Safety Director, Dr Aidan Fowler, said:

“Valproate is the best treatment available for a small group of people with very complex illnesses, so it’s vital those who have an active prescription for it to continue taking it until they are told otherwise by their GP or consultant.

“It’s vital too however that everyone understands the risk that doing so poses to your unborn child if you are pregnant, and this letter is a reminder of information that every woman and girl of childbearing age should receive from their doctors when the drug is first prescribed”.

Sodium valproate was approved for use in 1974 and has always carried warnings for doctors about the possible risks if it is taken while pregnant. These have been strengthened over the decades as more data has become available about higher rates of physical birth defects, autism and child developmental problems.

Due to this risk, in 2018 the heads of all medicines agencies in the UK issued a joint edict saying that all women and girls who could potentially conceive should be provided with and urged to use contraception for as long as they are taking valproate, even if they are not sexually active.

Doctors are expected to discuss the risks with patients as part of the shared decision around prescribing valproate, and put in place a pregnancy prevention plan to eliminate risk if it is prescribed, or use other forms of treatment if the patient wishes to have a baby.

Emma Murphy – Managing Director of INFACT

“We welcome this letter of communication being sent to all females of childbearing age informing them of the risks of Valproate in Pregnancy. This is something that should have been done from the very beginning and it has been a long and arduous campaign by INFACT to reach this goal. We are not only glad for ourselves that now Governing Bodies are taking these steps but most importantly for the patients prescribed the drug and the potential damage to the lives of unborn children”

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