Valproate – contraindicated in women of childbearing potential

You have probably heard about this on the news, or seen it in other forms, but in case you have missed it, I felt it important to do an update. This information came out in Apr 18 from MHRA.

Valproate is contraindicated for any reason, unless a Pregnancy Prevention Programme is in place (see below).

It is also contraindicated in pregnancy. The only exception is in epilepsy where it may not be feasible to change medications.

Why has this changed?

There is new information on the prevalence of defects associated with its use:

10% birth defects

  • Spina Bifida
  • Facial and skull bone malformations, including cleft lip and palate.
  • Malformation of the limbs, heart, kidneys, urinary tract and sexual organs.

30 to 40% developmental defects.

  • Late to walk and talk.
  • Lower intelligence than children of a similar age.
  • Poor speech and language skills.
  • Memory problems.
  • Autism/autism spectrum disorders.
  • Possible increased risk of ADHD

What is the Pregnancy Prevention Programme?

  1. All women started on valproate, or being reviewed for valproate use must be informed of the risks in pregnancy (there will be a patient guide available and is already a patient leaflet). They must sign a Risk Acknowledgement Form. This form doesn't seem to be available yet as far as I can see, but should be soon via the above weblink. The advice is that it is for the specialist and the patient at initiation and at annual review. If women haven't been seen in the last year by their specialist, then we should refer them back.
  2. Women should be on highly effective contraception (unless the prescriber feels that there are 'compelling reasons to indicate that there is no risk of pregnancy')
  3. All women should see their specialist annually.

So what must be done before initiation?

  • A plasma pregnancy test.
  • Information given to the woman.
  • Risk acknowledgement form.
  • Contraception.

What contraception is advised?

  • Cu-IUD (copper coil)
  • LNG-IUS (mirena)
  • Progesterone implant
  • Male and female sterilisation

If a user-independent form of contraception is not used, then 2 forms on contraception, including a barrier method, should be used and regular pregnancy testing should be considered.

 

I’m a freelance GP locum in Winchester & Southampton.

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